Bismuth quadruple three-in-one single capsule three times a day increases effectiveness compared with the usual four times a day schedule: results from the European Registry on Helicobacter pylori Management (Hp-EuReg).

BACKGROUND: The recommended schedule for single capsule bismuth quadruple therapy (scBQT, Pylera) includes a proton pump inhibitor (PPI) two times a day and three scBQT capsules four times a day. Four times a day treatments are inconvenient and reduce adherence. In contrast, adherence improves with three times a day schedules. In clinical practice, many gastroenterologists use four capsule scBQT three times a day. However, the effectiveness and safety of this latter approach remain uncertain. AIM: To assess the effectiveness and safety of scBQT administered three times a day in the patients included in the European Registry on Helicobacter pylori Management (Hp-EuReg). METHODS: All Spanish adult patients registered in the Asociación Española de Gastroenterología Research Electronic Data Capture (REDCap) database from June 2013 to March 2021 receiving 10-day scBQT were analysed. Modified intention-to-treat effectiveness, adherence and the safety of scBQT given three times a day were calculated and compared with the four times a day schedule. A multivariate analysis was performed to determine independent factors predicting cure of the infection. RESULTS: Of the 3712 cases, 2516 (68%) were four times a day and 1196 (32%) three times a day. Mean age was 51 years, 63% were women and 15% had a peptic ulcer. The three times a day schedule showed significantly better overall cure rates than four times a day (1047/1112, 94%; 95% CI 92.7 to 95.6 vs 2207/2423, 91%; 95% CI 89.9 to 92.2, respectively, p=0.002). Adherence and safety data were similar for both regimens. In the multivariate analysis, three times a day dosage, first-line therapy, use of standard or high-dose PPIs and adherence over 90% were significantly associated with cure of the infection. CONCLUSIONS: ScBQT prescribed three times a day was more effective than the traditional four times a day schedule. No differences were observed in treatment adherence or safety.

Effectiveness and Safety of Ustekinumab in Ulcerative Colitis: Real-world Evidence from the ENEIDA Registry.

BACKGROUND AND AIMS: The development programm UNIFI has shown promising results of ustekinumab in ulcerative colitis [UC] treatment which should be confirmed in clinical practice. We aimed to evaluate the durability, effectiveness, and safety of ustekinumab in UC in real life. METHODS: Patients included in the prospectively maintained ENEIDA registry, who received at least one intravenous dose of ustekinumab due to active UC [Partial Mayo Score [PMS]>2], were included. Clinical activity and effectiveness were defined based on PMS. Short-term response was assessed at Week 16. RESULTS: A total of 95 patients were included. At Week 16, 53% of patients had response [including 35% of patients in remission]. In the multivariate analysis, elevated serum C-reactive protein was the only variable significantly associated with lower likelihood of achieving remission. Remission was achieved in 39% and 33% of patients at Weeks 24 and 52, respectively; 36% of patients discontinued the treatment with ustekinumab during a median follow-up of 31 weeks. The probability of maintaining ustekinumab treatment was 87% at Week 16, 63% at Week 56, and 59% at Week 72; primary failure was the main reason for ustekinumab discontinuation. No variable was associated with risk of discontinuation. Three patients reported adverse events; one of them had a fatal severe SARS-CoV-2 infection. CONCLUSIONS: Ustekinumab is effective in both the short and the long term in real life, even in a highly refractory cohort. Higher inflammatory burden at baseline correlated with lower probability of achieving remission. Safety was consistent with the known profile of ustekinumab.

European Registry on Helicobacter pylori Management: Effectiveness of First and Second-Line Treatment in Spain.

The management of Helicobacter pylori infection has to rely on previous local effectiveness due to the geographical variability of antibiotic resistance. The aim of this study was to evaluate the effectiveness of first and second-line H. pylori treatment in Spain, where the empirical prescription is recommended. A multicentre prospective non-interventional registry of the clinical practice of European gastroenterologists concerning H. pylori infection (Hp-EuReg) was developed, including patients from 2013 until June 2019. Effectiveness was evaluated descriptively and through a multivariate analysis concerning age, gender, presence of ulcer, proton-pump inhibitor (PPI) dose, therapy duration and compliance. Overall, 53 Spanish hospitals were included, and 10,267 patients received a first-line therapy. The best results were obtained with the 10-day bismuth single-capsule therapy (95% cure rate by intention-to-treat) and with both the 14-day bismuth-clarithromycin quadruple (PPI-bismuth-clarithromycin-amoxicillin, 91%) and the 14-day non-bismuth quadruple concomitant (PPI-clarithromycin-amoxicillin-metronidazole, 92%) therapies. Second-line therapies were prescribed to 2448 patients, with most-effective therapies being the triple quinolone (PPI-amoxicillin-levofloxacin/moxifloxacin) and the bismuth-levofloxacin quadruple schemes (PPI-bismuth-levofloxacin-amoxicillin) prescribed for 14 days (92%, 89% and 90% effectiveness, respectively), and the bismuth single-capsule (10 days, 88.5%). Compliance, longer duration and higher acid inhibition were associated with higher effectiveness. "Optimized" H. pylori therapies achieve over 90% success in Spain.

Poor Sensitivity of Fecal Gluten Immunogenic Peptides and Serum Antibodies to Detect Duodenal Mucosal Damage in Celiac Disease Monitoring.

A lifelong gluten-free diet (GFD) is the only current treatment for celiac disease (CD), but strict compliance is complicated. Duodenal biopsies are the "gold standard" method for diagnosing CD, but they are not generally recommended for disease monitoring. We evaluated the sensitivity and specificity of fecal gluten immunogenic peptides (GIPs) to detect duodenal lesions in CD patients on a GFD and compared them with serum anti-tissue transglutaminase (tTG) IgA antibodies. A prospective study was conducted at two tertiary centers in Spain on a consecutive series of adolescents and adults with CD who maintained a long-lasting GFD. Adherence to a GFD and health-related quality of life were scored with validated questionnaires. Mucosal damage graded according to the Marsh-Oberhüber classification (Marsh 1/2/3) was used as the reference standard. Of the 97 patients included, 27 presented duodenal mucosal damage and 70 had normal biopsies (Marsh 0). The sensitivity (33%) and specificity (81%) of GIPs were similar to those provided by the two assays used to measure anti-tTG antibodies. Scores in questionnaires showed no association with GIP, but an association between GIPs and patients' self-reported gluten consumption was found (p = 0.003). GIP displayed low sensitivity but acceptable specificity for the detection of mucosal damage in CD.

Drug consumption and additional risk factors associated with microscopic colitis: Case-control study.

BACKGROUND: Microscopic colitis has now emerged as a common cause of chronic diarrhoea, but its aetiology remains unknown. Some studies suggest that commonly prescribed drugs and other additional risk factors may be triggers. AIMS: To evaluate the effects of drug intake and other risk factors on microscopic colitis patients. METHODS: A prospective, case-control study with all consecutive adult patients referred to the Hospital General de Tomelloso (Ciudad Real, Spain) for chronic watery diarrhoea (from 2008 to 2011) was performed. Microscopic colitis was diagnosed following the commonly accepted histopathological criteria. RESULTS: 46 consecutive new cases of microscopic colitis and 317 chronic diarrhoea controls were recruited. Five independent risk factors significantly associated with microscopic colitis were identified: Abdominal pain (OR 3.25; 95%CI, 1.49-7.08), weight loss (OR 2.67; 95%CI, 1.16-6.15), celiac disease (OR 15.3; 95%CI, 3.70-63.5), topiramate intake (OR 13.6; 95%CI, 1.84- 100.8), and older age at diagnosis (OR 1 year increase 1.022; 95%CI, 1.002-1.042). Use of non-steroidal anti-inflammatory drugs was associated with microscopic colitis in the subgroup of patients who fulfilled irritable bowel syndrome criteria (38.5% vs. 10.8%; p < 0.017). CONCLUSIONS: Microscopic colitis is associated with autoimmune disease, an increased age at diagnosis, topiramate intake and only in a sub-group of irritable bowel disease patients with non-steroidal anti-inflammatory drugs.

Drug consumption and additional risk factors associated with microscopic colitis: case-control study

BACKGROUND: Microscopic colitis has now emerged as a common cause of chronic diarrhoea, but its aetiology remains unknown. Some studies suggest that commonly prescribed drugs and other additional risk factors may be triggers. AIMS: To evaluate the effects of drug intake and other risk factors on microscopic colitis patients. METHODS: A prospective, case-control study with all consecutive adult patients referred to the Hospital General de Tomelloso (Ciudad Real, Spain) for chronic watery diarrhoea (from 2008 to 2011) was performed. Microscopic colitis was diagnosed following the commonly accepted histopathological criteria. RESULTS: 46 consecutive new cases of microscopic colitis and 317 chronic diarrhoea controls were recruited. Five independent risk factors significantly associated with microscopic colitis were identified: Abdominal pain (OR 3.25; 95%CI, 1.49-7.08), weight loss (OR 2.67; 95%CI, 1.16-6.15), celiac disease (OR 15.3; 95%CI, 3.70-63.5), topiramate intake (OR 13.6; 95%CI, 1.84- 100.8), and older age at diagnosis (OR 1 year increase 1.022; 95%CI, 1.002-1.042). Use of non-steroidal anti-inflammatory drugs was associated with microscopic colitis in the subgroup of patients who fulfilled irritable bowel syndrome criteria (38.5% vs. 10.8%; p < 0.017). CONCLUSIONS: Microscopic colitis is associated with autoimmune disease, an increased age at diagnosis, topiramate intake and only in a sub-group of irritable bowel disease patients with non-steroidal anti-inflammatory drugs

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Two-week, high-dose proton pump inhibitor, moxifloxacin triple Helicobacter pylori therapy after failure of standard triple or non-bismuth quadruple treatments.

BACKGROUND: Aim was to evaluate the efficacy and tolerability of a moxifloxacin-containing second-line triple regimen in patients whose previous Helicobacter pylori eradication treatment failed. METHODS: Prospective multicentre study including patients in whom a triple therapy or a non-bismuth-quadruple-therapy failed. Moxifloxacin (400mg qd), amoxicillin (1g bid), and esomeprazole (40 mg bid) were prescribed for 14 days. Eradication was confirmed by (13)C-urea-breath-test. Compliance was determined through questioning and recovery of empty medication envelopes. RESULTS: 250 patients were consecutively included (mean age 48 ± 15 years, 11% with ulcer). Previous (failed) therapy included: standard triple (n = 179), sequential (n = 27), and concomitant (n = 44); 97% of patients took all medications, 4 were lost to follow-up. Intention-to-treat and per-protocol eradication rates were 82.4% (95% CI, 77-87%) and 85.7% (95% CI, 81-90%). Cure rates were similar independently of diagnosis (ulcer, 77%; dyspepsia, 82%) and previous treatment (standard triple, 83%; sequential, 89%; concomitant, 77%). At multivariate analysis, only age was associated with eradication (OR = 0.957; 95% CI, 0.933-0.981). Adverse events were reported in 25.2% of patients: diarrhoea (9.6%), abdominal pain (9.6%), and nausea (9.2%). CONCLUSION: 14-day moxifloxacin-containing triple therapy is an effective and safe second-line strategy in patients whose previous standard triple therapy or non-bismuth quadruple (sequential or concomitant) therapy has failed, providing a simple alternative to bismuth quadruple regimen.

Epidemiology and temporal trends (2000-2012) of inflammatory bowel disease in adult patients in a central region of Spain.

BACKGROUND AND AIM: A growing incidence of inflammatory bowel disease (IBD) has been reported recently in southern Europe, with records of pediatric cases confirming these tendencies in Spain. Data on adult populations, however, have not been provided for over 10 years and need to be updated. PATIENTS AND METHODS: A multicenter retrospective registry of all adult patients with a diagnosis of IBD, including both Crohn's disease (CD) and ulcerative colitis (UC), attending five public hospitals covering a population of 514 368 inhabitants, was assessed. RESULTS: In 2012, the prevalence of CD and UC in adults was 137.17/100 000 inhabitants (95% confidence interval 114-160) and 99.84/100 000 inhabitants (95% confidence interval 79-119), respectively. The mean incidence rate during the period 2000-2012 of CD and UC was 8.9 and 5.6/100 000 inhabitants per year, respectively. Most of our patients (75.55%) had been diagnosed during the last 13 years. CD affected both sexes equally; a trend toward a progressive increase in the age at diagnosis, ileal location, and inflammatory behavior was documented for CD patients. In contrast, UC affected male patients with a higher frequency (57.8%; P=0.015), specifically those older than 40 years of age. Age at UC onset tended to increase progressively from 2000 to 2012 (P<0.001), but the extension on the disease remained unchanged. CONCLUSION: IBD is a highly prevalent disorder in our region, reaching the incidence of CD similar to the figures provided for Northern Europe. Changes in IBD localization, behavior, and age at diagnosis were documented during the period 2000-2012.

Same-day bidirectional endoscopy with nonanesthesiologist administration of propofol: safety and cost-effectiveness compared with separated exams.

BACKGROUND AND AIM: The safety and cost-effectiveness of a combination of esophagogastroduodenoscopy (EGD) and colonoscopy [or bidirectional endoscopy (BDE)] versus alternative-day EGD and colonoscopy when using nonanesthesiologist administration of propofol have never been evaluated. PATIENTS AND METHODS: This was a single-center prospective registry of consecutive American Society of Anaesthesiology class I-III outpatients undergoing EGD, colonoscopy, and BDE. Propofol was the sole sedative used. Adverse events, recovery time, and procedure-related costs were analyzed. RESULTS: Among the 1500 study participants (51.5% women), EGD, colonoscopy, and BDE were carried out on 449, 702, and 349 patients, respectively. All patients were discharged directly from the endoscopy unit. No sex differences were found with respect to age (mean 54.4, range 18-96 years), BMI, or procedure type. Propofol doses for BDE were 25.9% less than when EGD and colonoscopy were performed separately (P<0.001). Adverse events, including transient O2 saturation less than 90%, systolic blood pressure less than 90 mmHg, and bradycardia (<50 bpm), appeared in 10.7% of single EGD and 8.6% of EGD within BDE; for colonoscopies, the figures were 8.6 and 9.5%, respectively (P=NS). Recovery time to discharge after BDE was 47.9% shorter than when EGD and colonoscopy were performed separately (P<0.001). The cost of same-day BDE was 28.1% lower than that of EGD and colonoscopy performed as separated procedures (P<0.001). CONCLUSION: Same-day BDE with nonanesthesiologist administration of propofol resulted in reductions in propofol doses, recovery time, and procedure-related costs as compared with carrying out EGD and colonoscopy separately, without an increase in adverse events.

The relationship between proximal and distal colonic adenomas: is screening sigmoidoscopy enough in the presence of a changing epidemiology?

BACKGROUND AND STUDY AIMS: Because the relationship between distal and proximal colonic findings remains uncertain, controversy exists over whether proctosigmoidoscopy or colonoscopy is more suitable for colorectal cancer (CRC) screening. We aim to describe the distribution and characteristics of polyps removed in colonoscopy screening. PATIENTS AND METHODS: A prospective registry of a colonoscopy-based CRC screening program was developed on asymptomatic individuals over 50 years. All polyps were removed and characterized. Polyp size and histology were noted. Adenomas were considered advanced if they measured greater than 10 mm or were tubulovillous, villous, or malignant. The prevalence of advanced proximal polyps was determined and patients were categorized according to their family history of CRC. RESULTS: A total of 696 individuals (418 women), aged 57.7 ± 10.3 years, were examined; 45.8% presented a colonic lesion, being adenomatous polyps in 32.7% individuals. Among these, 24.7% were advanced adenomas. Three patients (0.6%) presented invasive CRC. There were no significant differences with respect to sex and family history of CRC between patients with or without adenomas. Adenomas were more prevalent in individuals aged at least 65, irrespective of location (P<0.001). In 65.1% of individuals with adenomatous polyps in the right colon, there were no synchronous adenomas in the left colon (P<0.001). More adenomas were also present in the right colon of patients with no family history of CRC (P<0.001). CONCLUSION: Most patients with adenomatous polyps in the right colon showed no synchronic adenomas on the left side. Lesions on the right side would have gone undetected if the individuals undergoing CRC screening had been explored with proctosigmoidoscopy.

Empiric 6-food elimination diet induced and maintained prolonged remission in patients with adult eosinophilic esophagitis: a prospective study on the food cause of the disease.

BACKGROUND: Although empiric exclusion from the diet of the 6 food groups most likely to trigger allergies achieves eosinophilic esophagitis (EoE) remission in children, data on its prolonged efficacy and effects on adults are lacking. OBJECTIVE: We sought to evaluate the efficacy of a 6-food elimination diet in inducing and maintaining prolonged remission in patients with adult EoE. METHODS: Sixty-seven consecutive patients with adult EoE were prospectively recruited and treated exclusively with a diet avoiding cereals, milk, eggs, fish/seafood, legumes/peanuts, and soy for 6 weeks. Subsequent challenge was undertaken by sequentially reintroducing all excluded single foods, followed by endoscopy and biopsies, which were developed every 6 weeks in case of response (eosinophil peak count reduction to <15/high-power field [hpf]). A food was considered a trigger for EoE and removed from the diet if pathologic eosinophilic infiltration (≥15 eosinophils/hpf) reappeared. Food-specific serum IgE measurements and skin prick tests were performed before initiating the diet. RESULTS: Forty-nine (73.1%) patients exhibited significantly reduced eosinophil peak counts (<15 eosinophils/hpf) before sequential single-food reintroduction. A single offending food antigen was identified in 35.71% of patients, 2 food triggers were identified in 30.95%, and 3 or more food triggers were identified in 33.3%. Cow's milk was the most common food antigen (61.9%), followed by wheat (28.6%), eggs (26.2%), and legumes (23.8%). Prior allergy tests showed no concordance with food-reintroduction challenge results. All patients who continued to avoid the offending foods maintained histopathologic and clinical EoE remission for up to 3 years. CONCLUSIONS: An empiric 6-food elimination diet effectively induced remission of active adult EoE, which was maintained for up to 3 years with individually tailored, limited exclusion diets.

Nonanesthesiologist-administered propofol sedation for colonoscopy is safe and effective: a prospective Spanish study over 1000 consecutive exams.

BACKGROUND AND STUDY AIMS: Propofol is increasingly being used in sedated colonoscopy. This paper assesses the safety and efficacy of nonanesthesiologist-administered propofol in a large series of colonoscopies. PATIENTS AND METHODS: A prospective registry of consecutive American Society of Anesthetics (ASA) class I and II outpatients undergoing colonoscopy was carried out. Propofol, administered by a nurse under an endoscopist's supervision, was the sole sedative agent used. RESULTS: Of the 1000 patients (563 women/437 men, mean age 57, range 8-89 years) included in the study, 57.4% showed ASA I and 42.6% ASA II characteristics. The cecal intubation rate was 96.9%. 48.2% of the procedures were for therapeutic purposes. The mean propofol dose was 177 mg (range 50-590 mg). Doses correlated inversely with patient age (r=-0.38; P<0.001) and were lower in ASA II patients (P<0.001) and in diagnostic (rather than therapeutic) exams (P<0.001). The average recovery time (from extracting the colonoscope to patient discharge) was 18.6 min (range 4-75) and longer in ASA II patients (P=0.05). A pulse oximetry saturation of less than 90% and a decrease in systolic blood pressure of more than 20 mmHg were observed in 24 (2.4%) and 385 (35.8%) patients, respectively. Both events were more frequent in patients older than 65 years (P<0.05); the latter was more common in ASA II patients. CONCLUSION: Colonoscopy under endoscopist-controlled propofol sedation in low-risk patients is safe and effective, allowing for a complete exploration, although patients at least 65 years old and/or classified as ASA II are more likely to present a decrease in blood pressure and have a prolonged recovery time.

Successful food elimination therapy in adult eosinophilic esophagitis: not all patients are the same.

Eosinophilic esophagitis (EoE) is a chronic, immune/antigen-mediated, esophageal disease characterized by esophageal dysfunction and eosinophilic inflammation, manifested mainly as dysphagia and frequent food impaction. EoE is recognized into the spectrum of food allergy, but food sensitization studies used not to be efficient to identify the triggering food, because of what patients are frequently treated with topic steroids or even endoscopic esophageal dilation. Herein, we describe 3 adult patients-all suffering from EoE, but with different sensitization patterns-who were treated successfully with elimination diets. Allergy tests indicated no food sensitization for patient 1, but challenge with milk and wheat were positive. Food IgE-mediated allergies were found in patients 2 and 3; inflammation was resolved with food elimination. Lack of food allergy sensitization does not exclude the possibility of food allergies as a cause of EoE; elimination diets must therefore be considered as an effective diagnostic and treatment tool.

Montelukast was inefficient in maintaining steroid-induced remission in adult eosinophilic esophagitis.

BACKGROUND AND AIMS: Leukotriene D4 is produced by and functions as a chemotactic factor for eosinophils. Eosinophilic esophagitis (EoE) is characterized by esophageal eosinophilic infiltration, determining structural changes and dismotility symptoms. Montelukast, a selective leukotriene D4 receptor antagonist, has gained increasing consideration as a therapeutic agent for EoE. However, limited available information has shown that montelukast is not effective in reducing eosinophilic infiltration. Our paper aims at evaluating whether montelukast could be consider as a steroid-sparing therapy by assessing its efficacy in maintaining both clinical and histopathological remission achieved after topical corticosteroids in adult EoE patients. METHODS: Eleven consecutively diagnosed adult EoE patients were prospectively studied. Esophageal biopsies were obtained before and after a 6-month treatment with fluticasone propionate 400 µg/twice a day. Immediately after that, montelukast 10 mg/day was instituted. A new endoscopy was foreseen after a new 3-month period, or as soon as the patients presented esophageal symptoms. Symptoms were assessed by using a questionnaire before and after fluticasone propionate treatment and after montelukast therapy. RESULTS: Eosinophils density into the esophageal epithelium and lamina propria was significantly reduced after a 6-month treatment with topical steroids (P = 0.003) and increased to levels similar to baseline level into the first 3 months after treatment with montelukast. Baseline symptom scores significantly decreased after treatment with topical steroids (P = 0.003) and increased again after montelukast therapy, but baseline levels improved. CONCLUSIONS: Montelukast was not efficient in maintaining the histopathological or clinical response achieved by topical steroids in adult EoE patients.