Frequency of Functional Constipation in Lebanese Children: A Cross-Sectional Study Based on Parental Reporting.

Aim: To determine the frequency and possible associated dietary and environmental factors of functional constipation (FC) among children in Lebanon followed at a single pediatric health system. Method: A prospective cross-sectional study was conducted in all pediatrics clinics at the American University of Beirut Medical Center (AUBMC). Children aged 2-7 years presenting for a well-child visit were recruited. Data relating to the child's bowel habits and other history items were obtained from parental questionnaires. Results: The mean age of the 172 recruited participants was 4.94 years with 56.4% being males. FC was present in 32.6% of the participants. Although there was no difference in the frequency of FC based on age and gender, the peak frequency of FC was at 5 years. The daily frequency of withholding stools was 64.3%, and 46.6% of the children with FC always experienced straining while stooling for the past 2 months. Decreased physical activity and diet were not significantly associated with FC. Conclusion: The present study shows that 32.6% of children aged 2-7 years in Lebanon suffer from constipation while only 51.7% of the recruited children's physicians inquire about the child's bowel movement during the well check visit. These numbers highlight the need to raise more awareness among pediatricians on the need to screen for constipation during clinic visits as a standard of care practice.

Addressing GI Health Through the Bidirectional Modulation of the Gut-Brain Axis With Herbal Extracts: A Narrative Review.

Functional gastrointestinal disorders (FGIDs) refer to a group of disorders with chronic symptoms, such as abdominal pain, dysphagia, dyspepsia, diarrhea, constipation, and bloating. Among these, functional constipation significantly impacts the quality of life and is linked with comorbidities, such as anxiety and depression. The exact pathophysiology remains unclear despite the widespread occurrence. Research suggests that the gut-brain axis plays a role in FGIDs. Disruptions in the bidirectional communication between the brain and gastrointestinal (GI) tract contribute to GI symptoms and mood disturbances. The incomplete understanding of FGID pathophysiology has led to limited treatment options. Traditional treatments often focus on single symptoms and come with side effects, prompting the need for alternative approaches that address both GI and psychological components. Alternative approaches including herbal supplements offer a natural alternative to conventional medicine by promoting regularity and gut health. Abelmoschus esculentus L. or okra has a history of use in traditional medicine. Bioactive compounds such as polysaccharides and fibers found in okra offer gastroprotective benefits. Withania somnifera is a plant commonly referred to as ashwagandha. The plant root has been used for its health-promoting effects. Research supports the use of W. somnifera to help with stress and sleep. Digexin is a herbal supplement combining W. somnifera (ashwagandha) and A. esculentus (okra). It has shown promise in improving both GI regularity and mood by modulating the gut-brain axis. Clinical studies support the potential of a novel herbal supplement that aids in the management of FGIDs. This narrative review looks at FGIDs, etiologies, current treatment, and possible therapeutic supplements to aid in symptom management.

Anorectal physiology and colonic motility in children with a history of tethered cord syndrome.

OBJECTIVES: The understanding of the impact of tethered cord syndrome (TCS) on the physiology of the colorectal area is limited. Our aim was to describe anorectal and colonic motility in children with TCS and compare the findings to those of children with functional constipation (FC). METHODS: We conducted a retrospective review of children with TCS who had an anorectal manometry (ARM) performed at our institution from January 2011 to September 2023. We recorded demographics, medical and surgical history, clinical symptoms, and treatment at time of ARM, ARM findings (resting pressure, push maneuver, rectal sensation, rectoanal inhibitory reflex [RAIR], and RAIR duration), and the final interpretation of colonic manometry (CM) if performed. We identified age and sex-matched control groups of children with FC. RESULTS: We included 24 children with TCS (50% female) who had ARM testing (median age at ARM 6.0 years, interquartile range 4.0-11.8 years). All children had constipation at time of ARM. Nineteen children had detethering surgery before ARM was performed. No significant differences in ARM parameters were found between children who had detethering surgery before ARM and children with FC. Among the 24 children, 14 also had a CM performed (13/14 after detethering surgery). No significant differences in colonic motility were found between children with a history of TCS and children with FC. CONCLUSIONS: Anorectal physiology and colonic motility are similar between children with a history of TCS and children with FC, suggesting that the underlying pathophysiology of defecatory disorders in children with and without history of TCS is similar.

Effect of thumbtack needle on functional constipation: A pragmatic randomized controlled trial.

OBJECTIVE: Thumbtack Needling (TN) has been employed in the treatment of functional constipation (FC), although the existing evidence supporting its effectiveness is limited. This study is to evaluate the efficacy of TN in ameliorating FC. METHOD: A total of 482 eligible patients were recruited and randomly assigned to the TN group or the Mosapride Citrate (MC) group. The TN was buried once for three days, rest for one day after two consecutive burials, followed by a 4-week follow-up. The primary outcome measure was the score for Complete and spontaneous bowel movement score (CSBMs). Secondary outcome measures included the Bristol Stool Form Scale (BSFS), Cleveland Clinic Score (CCS), and the Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL). RESULTS: Out of the 482 patients randomized, 241 were allocated to each group. Of these, 216 patients (89.6 %) in both groups completed the intervention and follow-up. Compared with the baseline, the differences of CSBMs in TN group [1.76(95 % CI, 1.61 to 1.91)] and MC group [1.35(95 % CI, 1.20 to 1.50)] at week 4 meet the threshold for minimal clinically important difference (MCID). However, there were no clinical difference from baseline at week 2 and week 8 in both groups. Mean CSBMs at week 4 was 3.35 ± 0.99 in the TN group and 3 ± 1.03 in the MC group (adjusted difference between groups, 0.37 points [95 % CI, 0.18 to 0.55]; P < 0.001), although differences between the two groups did not meet the MCID threshold. CONCLUSION: Compared with mosapride citrate, thumbtack needling produced a greater improvement in CSBMs, although the difference from control was not clinically significant. GOV IDENTIFIER: ChiCTR2100043684.

Management of functional constipation-associated halitosis: a retrospective study.

The features of functional constipation (FC)-associated halitosis were identified in the author's previous report. In this report, the author aimed to further investigate its treatment and efficacy. This retrospective study reviewed 100 FC patients, including 82 (82%) halitosis patients and 18 (18%) non-halitosis patients. They underwent the organoleptic test (OLT) to diagnose halitosis, and the organoleptic score (OLS) (0-5) was used to evaluated halitosis severity. The Cleveland Clinical Constipation Score (CCCS) (0-30) was used to evaluate FC severity. Patients were treated with the laxative polyethylene glycol electrolyte powder (PGEP) for four weeks. These tests were performed before and after treatment. The author found that, before treatment, the CCCS was 20.00 (18.00-23.00) for all patients, 21.00 (19.00-24.00) for halitosis patients, and 18.00 (17.00-18.25) for non-halitosis patients. A significant difference was observed between halitosis patients and non-halitosis patients (P< 0.001). The OLS for halitosis patients was 3.00 (3.00-4.00). A positive correlation (r= 0.814, 95% CI: 0.732-0.872,P< 0.001) was found between OLS and CCCS. A CCCS ⩾18 predicted over 50% probability of halitosis. After treatment, the CCCS significantly decreased to 11.50 (6.00-14.75) (P< 0.001), and OLS significantly decreased to 1.00 (0.00-2.00) (P< 0.001). A positive correlation (r= 0.770, 95% CI: 0.673-0.841,P< 0.001) persisted between OLS and CCCS. A pre-treatment CCCS ⩾21 predicted over 50% probability of post-treatment halitosis, while a post-treatment CCCS ⩾12 predicted over 50% probability of post-treatment halitosis. The author concludes that the severity of FC parallels the severity of FC-associated halitosis, and can predict the probability of halitosis. Laxative treatment with PGEP is effective in improving FC-associated halitosis.

Influence of the examination position and distension medium on the rectal sensory test in patients with functional constipation.

PURPOSE: To evaluate the impact of two different parameters (body position and distension medium) on the rectal sensory test in patients with functional constipation and provide data support for the development of standardized operating procedures in clinical practice. METHODS: Based on a single-center process of the rectal sensory test, 39 patients with functional constipation were recruited for rectal sensory test under different body positions and distension mediums. RESULTS: Among the items of the Constipation Scoring System, the score of frequency of bowel movements showed a negative correlation with the first constant sensation volume (r = -0.323, P = 0.045). Conversely, the score of painful evacuation effort showed a positive correlation with the desire to defecate volume (r = 0.343, P = 0.033). There was a statistically significant difference in the first constant sensation volume (when the distension medium was gas) measured in different body positions (left lateral position, sitting position, squatting position), and the data measured in the squatting position were significantly higher than those in left lateral position (P < 0.05). In terms of research on distension medium, it was found that the first constant sensation volume measured in the squatting position (when the distension medium was water) was significantly lower than that of gas (P < 0.05). CONCLUSION: For patients with functional constipation, there are differences in the results of rectal sensory tests between body positions and distension mediums. When conducting multicenter studies, it is necessary to unify the standard operating procedure (SOP) for operational details to ensure consistency and reliability of the test results.

Recent advances in treating constipation in children.

INTRODUCTION: Functional constipation (FC) is a common childhood condition, diagnosed via the Rome IV criteria. Standard therapy includes lifestyle and dietary modification followed by initiation of osmotic laxative therapy. About 30% of children continue to experience symptoms related to FC despite appropriate management. New pharmacologic, surgical, and neuromodulatory therapies for FC are now available for use in adult and pediatric populations. In 2023, the first pharmacologic agent, linaclotide, obtained FDA approval for treatment of FC in children 6-17 years old. AREAS COVERED: This article reviews current and emerging pharmacologic, surgical, and neuromodulation therapies for the management of FC in pediatric patients. Efficacy and safety data regarding each of these modalities was reviewed and discussed. EXPERT OPINION: Advancements in therapeutics available for the management of FC necessitate further investigation on safety and efficacy in pediatric populations. Careful consideration should be taken in choosing an available treatment with limited pediatric evidence as adult and pediatric FC have different underlying pathophysiology and require a different therapeutic approach. Standardization of methodology and pediatric endpoints are needed to optimize ability to compare efficacy of different treatments. We predict the future of pediatric FC management will include a personalized approach to care, resulting in improved outcomes.

Effectiveness of physiotherapy in children with functional constipation.

PURPOSE: The objective was to compare the immediate effects of pharmacological versus physiotherapy intervention versus a combination of physiotherapy and pharmacological treatment, as well as the quality of life and the recurrence of symptoms in children with functional constipation after 3 months. METHODS: A total of 69 children with functional constipation between the ages of 5 and 14 years of either gender were assessed and randomly assigned to one of three groups: Group A, B, and C. Visual Analogue Scale, Bristol Stool Form Scale, frequency of defecation, PedsQL GI symptom scale, and PedsQL Generic Core Scale were used as outcome measures. Pharmacology was used to treat Group A, physiotherapy was used to treat Group B, and a combination of both was used to treat Group C. RESULTS: The study revealed statistically significant results on Visual Analogue Scale, Bristol Stool Form Scale, and frequency of defecation in all groups. However, no significant changes were observed on the PedsQL GI symptom scale and the Generic Core scale in Group A, whereas significant changes were observed in Groups B and C. CONCLUSION: In this study, we found that there were significant differences in the short- and long-term effects across all groups. More changes occurred in Group C than in Groups A and B.

Effect of adding telerehabilitation home program to pharmaceutical treatment on the symptoms and the quality of life in children with functional constipation: a randomized controlled trial.

Painful defecation, the passage of hard stools, unpleasant or irregular bowel deviation/movements from regular rate, and/or the feeling of not enough elimination of stool are common symptoms of functional constipation. The goals in treating constipation are to produce soft, painless stools and to prevent the re-accumulation of feces. This study looked at how the telerehabilitation home program (TRP) affected the symptoms of FC and the children who were constipated in terms of their quality of life. A randomized controlled trial included 400 children aging 4-18 years with functional constipation distributed in two groups: control group consisted of 200 children receiving pharmaceutical treatment and the intervention group consisted of 200 children receiving the telerehabilitation home program in addition to pharmaceutical treatment. Both groups received the interventions for 6 months. The outcomes in terms of functional constipation symptoms and quality of life are measured and compared pre- and post-interventions. Adding the telerehabilitation home program to pharmaceutical treatment of functional constipation in children results in prominent improvement in the condition; there is a significant difference between the intervention and control group in all Rome criteria which assess symptoms of functional constipation except rush to the bath-room to poop which showed non-significant difference; there is also a significant difference between the intervention and control group in all domains of the SF-36 questionnaire which assess quality of life except the mental health domain which showed non-significant difference. CONCLUSION: Adding the telerehabilitation home program to pharmaceutical treatment of functional constipation in children results in prominent improvement in symptoms of functional constipation and quality of life. TRIAL REGISTRATION: Our study was registered retrospectively with Clinicaltrials.gov under the identifier NCT06207721 on 5 January 2024. WHAT IS KNOWN: • Painful defecation, passage of hard stools, unpleasant or irregular bowel movements, feeling of incomplete stool elimination are common symptoms of functional constipation. • Goals in treating constipation include producing soft, painless stools and preventing re-accumulation of feces. WHAT IS NEW: • Adding telerehabilitation home program to pharmaceutical treatment resulted in significant improvement in functional constipation symptoms and quality of life. • Significant differences between intervention group (200 children receiving telerehabilitation home program in addition to pharmaceutical treatment) and control group (200 children receiving pharmaceutical treatment) were observed in all Rome criteria except for rush to the bathroom to poop, and in all domains of SF36 questionnaire except for the mental health domain.

Laxative Weaning Protocol for Patients With Functional Constipation: A Pilot Study.

BACKGROUND: Children with functional constipation require prolonged laxative administration for proper emptying. Whether these laxatives can be weaned after better functioning is achieved is unknown. We aim to describe a standardized protocol for stimulant laxative weaning and its early outcomes. METHODS: Patients were candidates for weaning if they had been on a stable laxative dose for six months, defined as one bowel movement per day with no soiling, impaction, or enemas. Laxative dose was decreased by 10-25% with re-evaluation every two weeks. If patients remained well without constipation, dose was weaned further by 10-25%. If there were worsening of symptoms, lower dose was maintained for 3-6 months until re-evaluation. RESULTS: There were a total of sixteen patients evaluated. Median age was 12.7 years [IQR: 11.7-15.3] with laxative duration of 8.0 years [IQR: 5.4-10.7]. All patients were on senna; some were on fiber. Median starting senna dose was 71.3 mg [IQR: 54.3-75.0] and median fiber dose was 5.5 g [IQR: 4.0-6.0]. As of most recent follow up, nine patients (56.3%) had weaned off laxatives in 3.7 months [IQR: 1.3-11.6]. For those still on laxatives, median reduction in dose was 41.4 mg [30.0-75.0], and over half weaned their dose by >50%. Almost all (90.9%) of those on high doses were able to wean. CONCLUSION: A standardized laxative weaning process can be successful in patients with functional constipation, especially on high doses. Further prospective studies will be necessary to confirm the success of this protocol. LEVEL OF EVIDENCE: III.

A Novel Herbal Composition Alleviates Functional Constipation, Reduces Gastrointestinal Transit Time, and Improves Bowel Function in Adults: A Double-Blind, Randomized Clinical Study.

BACKGROUND AND OBJECTIVE: A recent proof-of-concept pilot clinical study has demonstrated that consumption of CL18100F4, a proprietary herbal blend of Withania somnifera root and Abelmoschus esculentus fruit extracts, significantly relieved the participants from functional constipation and improved their quality of life. The objective of the present randomized, double-blind, placebo-controlled study was to reevaluate the efficacy and tolerability of CL18100F4 in a larger number of subjects. METHODS: Male and female subjects (n = 135; age: 25-60 years), selected through Rome-IV criteria for functional constipation, were randomized into placebo and 300 or 500 mg of CL18100F4 groups and supplemented daily over 60 consecutive days. The primary efficacy outcome measure was Patient Assessment of Constipation-Symptoms (PAC-SYM), evaluated at baseline and on days 7, 30, and 60 of supplementation. The secondary efficacy parameters included Patient Assessment of Constipation-Quality of Life (PAC-QOL), Gastrointestinal Symptom Rating Scale (GSRS) scores, Gastrointestinal Transit Time (GIT), and Complete Spontaneous Bowel Movement (CSBM). Serum levels of Interleukin (IL)-6, IL-10, cortisol, gastrin, serotonin, Diamine oxidase (DAO), and Zonulin were measured. RESULTS: CL18100F4 supplementation significantly (p < 0.001) reduced the PAC-SYM, PAC-QOL, GSRS scores, and GIT and improved CSBM scores. CL18100F4 significantly improved (p < 0.001) sleep quality and decreased depression and anxiety symptoms in the participants. Notably, relief in constipation symptoms and improved gastrointestinal (GI) function were reported starting from day 7. Furthermore, CL18100F4 supplementation significantly (p < 0.001) increased the serum levels of IL-10, DAO, serotonin, gastrin, reduced IL-6, cortisol, and Zonulin. No major adverse events were observed. Participants' vital signs, hematology, clinical biochemistry, and urinalysis parameters were within the normal ranges. CONCLUSION: The present investigation demonstrates that CL18100F4 is tolerable and efficacious in relieving functional constipation, alleviating GI dysfunction, and improving associated non-GI factors in male and female adults.

Microbiota treatment of functional constipation: Current status and future prospects.

Functional constipation (FC) is a common disorder that is characterized by difficult stool passage, infrequent bowel movement, or both. FC is highly prevalent, recurs often, accompanies severe diseases, and affects quality of life; therefore, safe and effective therapy with long-term benefits is urgently needed. Microbiota treatment has potential value for FC treatment. Microbiota treatments include modulators such as probiotics, prebiotics, synbiotics, postbiotics, and fecal microbiota transplantation (FMT). Some probiotics and prebiotics have been adopted, and the efficacy of other microbiota modulators is being explored. FMT is considered an emerging field because of its curative effects; nevertheless, substantial work must be performed before clinical implementation.

Constipation and colonoscopy.

Constipation is a significant sociomedical problem, which can be caused by various reasons. In the diagnostic approach to patients with constipation, the following data are usually sufficient: History, complete physical examination (including rectal examination), and additional diagnostic tests. A colonoscopy is not a necessary diagnostic method for all patients with constipation. However, if patients have alarm symptoms/signs, that suggest an organic reason for constipation, a colonoscopy is necessary. The most important alarm symptoms/signs are age > 50 years, gastrointestinal bleeding, new-onset constipation, a palpable mass in the abdomen and rectum, weight loss, anemia, inflammatory bowel disease, and family history positive for colorectal cancer. Most endoscopists do not like to deal with patients with constipation. There are two reasons for this, namely the difficulty of endoscopy and the adequacy of preparation. Both are adversely affected by constipation. To improve the quality of colonoscopy in these patients, good examination techniques and often more extensive preparation are necessary. Good colonoscopy technique implies adequate psychological preparation of the patient, careful insertion of the endoscope with minimal insufflation, and early detection and resolution of loops. Bowel preparation for colonoscopy often requires prolonged preparation and sometimes the addition of other laxatives.

A survey on functional constipation and its risk factors in older people in Shahreza, Iran.

BACKGROUND: Functional constipation is prevalent among older people. It has major effects on the quality of life of them, as well as the high costs of treatment. This study investigated functional constipation and risk factors affecting older people living in Shahreza, Iran. MATERIALS AND METHODS: This cross-sectional study was performed on 200 older people in Shahreza. They were selected by simple random sampling. We used the Rome III Criteria, the Elderly Physical Activity Questionnaire (PASE), and related questions from the SIB system (integrated health system). After completing the questionnaires, the data were analyzed using the mean and standard deviation, Chi-square test, independent-samples t-test, Fisher's exact test, and Mann-Whitney test. RESULTS: The prevalence of functional constipation was 45%. There are significant relationships between functional constipation with dental problems (P = 0.02), intake of fluid (P = 0.001), fruits (P = 0.001), and vegetables (P < 0.001), polypharmacy (P = 0.003), and antidepressants (P = 0.008), history of colon (P = 0.003) and anal (P = 0.001) diseases, stroke or mobility disabilities (P = 0.002), the level of physical activity (P = 0.002), and gender (P = 0.04) in older people living in Shahreza. CONCLUSIONS: According to the high prevalence of functional constipation in the studied older people, it is necessary to focus on controlling risk factors and planning to prevent the destructive effects of social restrictions on older people during the coronavirus disease 2019 (COVID-19) pandemic.

Is Collaborative Care the Future of Medicine? Lessons Learned from the Care of Children with Colorectal Conditions.

The treatment of patients with colorectal disorders requires care from a wide variety of medical and surgical specialties over the course of their lifetime. This is ideally handled by a collaborative center which facilitates the assessment and development of patient care among multiple specialties which can enhance the quality and implementation of treatment plans, improve communication among different specialties, decrease morbidity, and improve patient satisfaction and outcomes. This collaborative approach can serve as a model for other parts of medicine requiring a similar multi-disciplinary and integrated method of care delivery. We describe the process, as well as the lessons learned in developing such a program.

Evaluation of the impact of overlapping upper gastrointestinal symptoms on the clinical characteristics of patients with functional constipation, along with risk factor analysis.

OBJECTIVES: Functional constipation (FC), a common functional gastrointestinal disorder, is usually overlapping with upper gastrointestinal symptoms (UGS). We aimed to explore the clinical characteristics of patients with FC overlapping UGS along with the related risk factors. METHODS: The differences in the severity of constipation symptoms, psychological state, quality of life (QoL), anorectal motility and perception function, autonomic function, and the effect of biofeedback therapy (BFT) among patients with FC in different groups were analyzed, along with the risk factors of overlapping UGS. RESULTS: Compared with patients with FC alone, those with FC overlapping UGS had higher scores in the Patient Assessment of Constipation Symptoms and Self-Rating Anxiety Scale and lower scores in the Short Form-36 health survey (P < 0.05). Patients with FC overlapping UGS also had lower rectal propulsion, more negative autonomic nervous function, and worse BFT efficacy (P < 0.05). Overlapping UGS, especially overlapping functional dyspepsia, considerably affected the severity of FC. Logistic regression model showed that age, body mass index (BMI), anxiety, exercise, and sleep quality were independent factors influencing overlapping UGS in patients with FC. CONCLUSIONS: Overlapping UGS reduces the physical and mental health and the QoL of patients with FC. It also increases the difficulty in the treatment of FC. Patient's age, BMI, anxiety, physical exercise, and sleep quality might be predictors for FC overlapping UGS.

Prevalence of irritable bowel syndrome and other functional gastrointestinal disorders in Uruguay.

INTRODUCTION AND AIMS: Irritable bowel syndrome (IBS) is one of the most frequent functional gastrointestinal disorders. Prevalence worldwide is estimated at 11%. There is little information on the prevalence of the other functional bowel disorders (FBDs). Our aim was to establish the prevalence of IBS and other FBDs according to the Rome IV criteria, in Uruguay. MATERIALS AND METHODS: An observational, population-based prevalence study was conducted. Data were collected through an online questionnaire, utilizing the Rome IV criteria. RESULTS: Of the 1,052 participants (79% women, mean patient age 44 years), 47.2% met the Rome IV diagnostic criteria for at least one of the FBDs analyzed. Functional constipation (FC) was the most frequent, at 18.7% (16.4-21.1), followed by IBS at 17.1% (14.9-19.4) and functional diarrhea (FD) at 15.4% (13.3-17.6). IBS with constipation (IBS-C) was the most frequent IBS subtype (35%) and the IBS with diarrhea (IBS-D) subtype predominated in men. All FBDs were more prevalent in women and youths. Of the survey participants with a FBD, 59% stated that they perceived no worsening of their symptoms related to the COVID-19 pandemic. CONCLUSIONS: Ours is the first prevalence study on FBDs conducted on the Uruguayan general population. Half of the participants surveyed presented with a FBD analyzed in the study. FC was the most frequent, followed by IBS and FD. The prevalence rate of IBS was the highest, based on the Rome IV diagnostic criteria, and constipation was the most frequent subtype.

Functional Constipation and Obstructed Defecation.

Constipation encompasses symptoms of decreased colonic motility or difficulty with the defecation process. As a broad definition, this can be inclusive of functional constipation (FC) or colonic inertia, obstructed defecation (OD), and irritable bowel syndrome-constipation type (IBS-CS). After excluding IBS-C, FC and OD diagnosis and management require a multidisciplinary approach often involving nutritionists, pelvic floor therapists, urogynecologists, and colon and rectal surgeons. Differentiating the presence or absence of each can direct therapy and prognosticate chances for improvement in this often complex combination of disorders.

Efficacy and mechanism of acupuncture for functional constipation in older adults: study protocol for a randomized controlled trial.

Introduction: Functional constipation (FC) is a common functional gastrointestinal disorder in clinical practice, with the prevalence of which increasing with age. With the increasing aging of the population worldwide, this problem is bound to become more prominent. Acupuncture is effective and recommended for the treatment of FC. However, little is known about how acupuncture affects the gut microbiota and inflammatory cytokines and thus improves gut function. Meanwhile, there are few high-quality clinical trials specifically focusing on acupuncture in treating FC in older people. The objective of this study is to assess the efficacy and safety of acupuncture in treating FC in older people. Additionally, the research aims to explore the mechanism of action of acupuncture in treating FC in older people by affecting intestinal microbiota and inflammation cytokines. Methods and analysis: This study is designed as a single-center, randomized, sham-controlled clinical trial. A total of 98 eligible FC patients will be randomized in a 1:1 ratio into an acupuncture group and a sham acupuncture group. Both groups will receive 24 treatments over 8 weeks with a 12-week follow-up. The primary outcome of the study is the treatment response rate, which is the proportion of participants with ≥3 mean weekly Complete Spontaneous Bowel Movements (CSBMs) over weeks 3-8. The secondary outcomes will include the proportion of participants with ≥3 mean weekly CSBMs during other assessment periods; the percentage of patients with ≥1 increase in mean weekly CSBMs from baseline; the average changes in CSBMs; Patient Assessment of Constipation-Symptoms (PAC-SYM), Bristol Stool Scale, Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS) and weekly usage of emergency bowel medications. Adverse events will be recorded throughout the study. Data for the outcomes will be collected at Week 0 (baseline), Week 4 (the intervention period), Week 8 (the post-treatment), Week 12 (the follow-up period) and Week 20 (the follow-up period). In addition, changes in intestinal microbiota will be analyzed using 16S rRNA high-throughput detection, and the concentration of relevant inflammatory cytokines in serum will be measured by ELISA based on blood samples. The intention-to-treat analysis will be performed in this study.Clinical trial registration: [https://www.chictr.org.cn/], identifier [ChiCTR2300070735].

A Low FODMAP Diet Supplemented with L-Tryptophan Reduces the Symptoms of Functional Constipation in Elderly Patients.

(1) Background: The elderly suffer from functional constipation (FC), whose causes are not fully known, but nutritional factors may play a role. The aim of the present study was to assess the effect of a low FODMAP diet supplemented with L-tryptophan (TRP) on its metabolism and symptoms of functional constipation in elderly patients. (2) Methods: This study included 40 people without abdominal complaints (Group I, controls) and 60 patients with FC, diagnosed according to the Rome IV Criteria (Group II). Two groups were randomly selected: Group IIA (n = 30) was qualified for administration of the low FODMAP diet, and the diet of patients of Group IIB (n = 30) was supplemented with 1000 mg TRP per day. The severity of abdominal symptoms was assessed with an abdominal pain index ranging from 1 to 7 points (S-score). The concentration of TRP and its metabolites, 5-hydroxyindoleacetic acid (5-HIAA), kynurenine (KYN), and 3-indoxyl sulfate (3-IS) in urine were determined using the LC-MS/MS method. (3) Results: In Group II, 5-HIAA concentration in urine was lower, and KYN and 3-IS concentrations were higher than in the control group. A negative correlation was found between the S-score and urinary concentration of 5-HIAA (p < 0.001), and 3-IS concentration was positively correlated with the S-score. However, the correlation between the S-score and 3-IS concentration was negative (p < 0.01). After a dietary intervention, 5-HIAA concentration increased in both groups, and the severity of symptoms decreased, but the decrease was more pronounced in Group IIB. (4) Conclusion: A low FODMAP diet supplemented with L-tryptophan has beneficial effects in elderly patients suffering from functional constipation.