Protein-based oral rehydration solutions for patients with an ileostomy: A randomised, double-blinded crossover study.

BACKGROUND & AIM: Patients with an ileostomy are at increased risk of dehydration and sodium depletion. Treatments recommended may include oral rehydration solutions (ORS). We aimed to investigate if protein type or protein hydrolysation affects absorption from iso-osmolar ORS in patients with an ileostomy. METHODS: This was a randomised, double-blinded, active comparator-controlled 3 × 3 crossover intervention study. We developed three protein-based ORS with whey protein isolate, caseinate or whey protein hydrolysate. The solutions contained 40-48 g protein/L, 34-45 mmol sodium/L and had an osmolality of 248-270 mOsm/kg. The patients ingested 500 mL/d. The study consisted of three 4-week periods with a >2-week washout between each intervention. The primary outcome was wet-weight ileostomy output. Ileostomy output and urine were collected for a 24-h period before and after each intervention. Additionally, blood sampling, dietary records, muscle-strength tests, bioimpedance analyses, questionnaires and psychometric tests were conducted. RESULTS: We included 14 patients, of whom 13 completed at least one intervention. Ten patients completed all three interventions. Wet-weight ileostomy output did not change following either of the three interventions and did not differ between interventions (p = 0.38). A cluster of statistically significant improvements related to absorption was observed following the intake of whey protein isolate ORS, including decreased faecal losses of energy (-365 kJ/d, 95% confidence interval (CI), -643 to -87, p = 0.012), potassium (-7.8 mmol/L, 95%CI, -12.0 to -3.6, p = 0.001), magnesium (-4.0 mmol/L, 95%CI, -7.4 to -0.7, p = 0.020), improved plasma aldosterone (-4674 pmol/L 95%CI, -8536 to -812, p = 0.019), estimated glomerular filtration rate (eGFR) (2.8 mL/min/1.73 m2, 95%CI, 0.3 to 5.4, p = 0.03) and CO2 (1.7 mmol/L 95%CI, 0.1 to 3.3, p = 0.04). CONCLUSION: Ingestion of 500 mL/d of iso-osmolar solutions containing either whey protein isolate, caseinate or whey protein hydrolysate for four weeks resulted in unchanged and comparable ileostomy outputs in patients with an ileostomy. Following whey protein isolate ORS, we observed discrete improvements in a series of absorption proxies in both faeces and blood, indicating increased absorption. The protein-based ORS were safe and well-tolerated. Treatments should be tailored to each patient, and future studies are warranted to explore treatment-effect heterogeneity and whether different compositions or doses of ORS can improve absorption and nutritional status in patients with an ileostomy. GOV STUDY IDENTIFIER: NCT04141826.

Osmolality in oral supplements drives ileostomy output: Defining the Goldilocks zone.

BACKGROUND: Patients with an ileostomy often have impaired quality of life, sodium depletion, secondary hyperaldosteronism, and other organ-specific pathologies. The osmolality of oral supplements influences ileostomy output and increases sodium loss. We hypothesized the existence of an osmolality range in which fluid absorption and secondary natriuresis are optimal. METHODS: This was a single-center, quasi-randomized crossover intervention study, including patients with an ileostomy and no home parenteral support. After an 8-h fasting period, each patient ingested 500 mL of 3-18 different oral supplements and a standardized meal during the various intervention periods, followed by a 6-h collection of ileostomy and urine outputs. The primary outcome was 6-h ileostomy output. RESULTS: A total of 14 ileostomy patients with a median age of 65 years (interquartile range 38-70 years) were included. The association between osmolalities (range 5-1352 mOsm/kg) and ileostomy output forecasted an S-curve. A linear association between osmolality of oral supplements (range 290-600 mOsm/kg) and ileostomy output was identified and assessed with a mixed-effects model. Ileostomy output increased by 57 g/6 h (95% confidence interval (CI) 21-94) when the oral supplement osmolality increased by 100 mOsm/kg (p = 0.005). CONCLUSION: Osmolality in oral supplements correlated with ileostomy output. Our results indicate that patients with an ileostomy may benefit from increased ingestion of oral supplements with osmolalities between 100 and 290 mOsm/kg. We define this range as the Goldilocks zone, equivalent to optimal fluid and electrolyte absorption.

Bioelectrical impedance analysis as a clinical marker of health status in adult patients with benign gastrointestinal disease: A systematic review.

BACKGROUND: Body composition reflects nutritional status, disease status and progression, and treatment responses. Mounting evidence supports the use of bioelectrical impedance analysis (BIA) as a non-invasive tool to assess body composition. Patients with benign gastrointestinal (GI) disease experience disease-related alterations in their body composition, and bioimpedance outcomes in patients with benign GI diseases have not previously been summarized. We aimed to evaluate BIA as a clinical body composition marker for benign GI diseases and describe its association with physical health status. METHODS: We systematically searched PubMed, Scopus, Web of Science, Embase, and CINAHL from inception to October 2023 (PROSPERO registration: CRD42021265866). Of 971 screened studies, 26 studies were included in the final analysis, comprising a total of 2398 adult patients with benign GI disease. The main outcome was raw impedance data. RESULTS: The most frequently reported BIA outcome was phase angle (PhA) (reported in 18 of 26 studies), followed by fat-free-mass (FFM) (reported in 13 of 26 studies). The consensus view of the included studies illustrates that BIA can be a useful tool for evaluating body composition in patients with benign GI diseases, and low PhA and FFM were associated with increased nutritional risk, abnormal physical characteristics, and increased mortality risk. CONCLUSION: To fully utilize BIA as a clinical marker of health in patients with benign GI disease, standardized protocols specific to this population are needed and prospective studies testing cut-offs and ranges, accuracy, and other raw BIA parameters for classifying disease status.

Sodium depletion and secondary hyperaldosteronism in outpatients with an ileostomy: a cross-sectional study.

OBJECTIVE: Patients with an ileostomy may experience postoperative electrolyte derangement and dehydration but are presumed to stabilise thereafter. We aimed to investigate the prevalence of sodium depletion in stable outpatients with an ileostomy and applied established methods to estimate their fluid status. METHODS: We invited 178 patients with an ileostomy through a region-wide Quality-of-Life-survey to undergo outpatient evaluation of their sodium and fluid status. The patients delivered urine and blood samples, had bioelectrical impedance analysis performed and answered a questionnaire regarding dietary habits. RESULTS: Out of 178 invitees, 49 patients with an ileostomy were included; 22 patients (45%, 95% CI, 31-59%) had unmeasurably low urinary sodium excretion (<20 mmol/L), indicative of chronic sodium depletion, and 26% (95% CI, 16-41%) had plasma aldosterone levels above the reference value. Patients with unmeasurably low urinary sodium excretion had low estimated glomerular filtration rates (median 76, IQR 63-89, mL/min/1.73m2) and low venous blood plasma CO2 (median 24, IQR 21-26, mmol/L), indicative of chronic renal impairment and metabolic acidosis. Bioelectrical impedance analysis, plasma osmolality, creatinine and sodium values were not informative in determining sodium status in this population. CONCLUSION: A high proportion of patients with an ileostomy may be chronically sodium depleted, indicated by absent urinary sodium excretion, secondary hyperaldosteronism and chronic renal impairment, despite normal standard biochemical tests. Sodium depletion may adversely affect longstanding renal function. Future studies should investigate methods to estimate and monitor fluid status and aim to develop treatments to improve sodium depletion and dehydration in patients with an ileostomy.IMPACT AND PRACTICE RELEVANCE STATEMENTSodium depletion in otherwise healthy persons with an ileostomy was identified in a few publications from the 1980s. The magnitude of the problem has not been demonstrated before. The present study quantifies the degree of sodium depletion and secondary hyperaldosteronism in this group, and the results may help guide clinicians to optimise treatment. Sodium depletion is easily assessed with a urine sample, and sequelae may possibly be avoided if sodium depletion is detected early and treated. This could ultimately help increase the quality of life in patients with an ileostomy.

Nutritional risk screening in a Danish university hospital is insufficient and may underestimate nutritional risk: A cross-sectional study.

BACKGROUND: Disease-related-malnutrition predicts poor clinical outcomes in elderly patients, and screening is pivotal for identifying patients at nutritional risk. The present study aimed to investigate nutrition screening rates in electronic patient records and validate the scores given. A secondary aim was to investigate whether the proportion of patients at risk differed between patients where screening was documented and those where no screening was documented. METHODS: This cross-sectional observational study was conducted in a Danish university hospital during November 2020. Patients aged 65 years or more admitted to a medical department were included. The Nutrition Risk Screening 2002 (NRS-2002) tool was used to identify patients at nutritional risk, both in routine clinical care, where data were collected retrospectively, and during a validation process in a random patient sample, where data were collected prospectively. RESULTS: In total, 817 patients were admitted for more than 24 h. Of these, an NRS-2002 score was documented in 294 (36%), among whom 177 (60%) were at nutritional risk. In 146 patients where no score was documented, 88 (60%) were at risk. Validation was possible in 91 patients where a record-based score and a validated score were documented. The specificity of the record-based score was 100%, whereas the sensitivity was 75%, indicating that routine screening underestimated nutritional risk (p < 0.001, proportion difference 19%; 95% confidence interval = 10%-28%). CONCLUSIONS: Electronic documentation does not solve issues about compliance with nutritional risk screening. In patients where screening was not documented, the occurrence of nutritional risk was similar, indicating that omission of screening is not related to the score.

Long-term maintenance treatment with 300 mg thiamine for fatigue in patients with inflammatory bowel disease: results from an open-label extension of the TARIF study.

OBJECTIVE AND AIMS: Fatigue is common in inflammatory bowel disease (IBD). In a RCT we demonstrated reductions in fatigue after 4 weeks' treatment with high-dose oral thiamine. We aimed to investigate whether 300 mg thiamine daily for 12 weeks could maintain the achieved levels of fatigue in patients with IBD after a 4-week intervention with high-dose thiamine; and evaluate the effect of a 6-month period where patients were free to take oral thiamine. METHODS: A randomised, open-label, controlled trial, performed as a long-term extension (LTE) study of an initial randomised, high-dose thiamine trial. Patients were allocated 1:1 to 300 mg oral thiamine or no thiamine for 12 weeks. Subsequently, the patients were allowed to self-treat with over-the-counter (OTC) oral thiamine 6-month. RESULTS: Regardless of allocation in the LTE study fatigue severity increased in the study period. No significant effect of 300 mg oral thiamine were found, when stratifying for initial allocation in the high-dose study or fatigue level at entry in the LTE study. Patients who took OTC thiamine had lower level of fatigue 6 month later (7.8; 95% CI: 5.5-10.1) when compared to the remains (11.0; 95% CI: 9.2-12.8) (p = .02). After the 6-months follow-up without restrictions, 66% of patients had reached normal fatigue levels. CONCLUSIONS: We found no beneficial effect on fatigue from thiamine taken in doses of 300 mg per day for 12 weeks following high-dose treatment. After a 6-months follow-up without restrictions 66% had reached a normal level of fatigue. CLINICAL TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov under study identifier NCT03634735.

Systematic review with meta-analysis: effects of implementing a nutrition support team for in-hospital parenteral nutrition.

BACKGROUND: Nutrition support teams (NST) may improve parenteral nutrition (PN) outcomes. No previous systematic review has provided conclusive data on catheter-related infection (CRI) occurrence after NST introduction, nor have previous studies performed meta-analysis or graded the evidence. AIMS: To systematically evaluate the effects of implementing an NST for hospitalised adults on PN and compare these with standard care. METHODS: This was a systematic review and meta-analysis, pre-registered in PROSPERO (CRD42020218094). On November 24, 2020, PubMed, Web of science, Scopus, Embase, Cochrane Library, and Clinical Key were searched. Clinical trials and observational studies with a standard care comparator were included. Primary outcome was relative reduction in CRI rate. A random-effects meta-analysis was used to estimate effects, and evidence was rated using Cochrane and GRADE methodologies. RESULTS: Twenty-seven studies with 8166 patients were included. Across 10 studies, NST introduction reduced the CRI rate (IRR = 0.32, 95% CI: 0.19-0.53) with -8 (95% CI: -12 to -5) episodes per 1000 catheter days compared with standard care. Hypophosphataemia occurred less frequently (IRD = -12%, 95% CI: -24% to -1%) and 30-day mortality decreased (IRD = -6%, 95% CI: -11% to -1%). Inappropriate PN use decreased, both judged by indication (IRD = -18%, 95% CI: -28% to -9%) and duration (IRD = -21%, 95% CI: -33% to -9%). Evidence was rated very low to moderate. CONCLUSIONS: This study documents the clinical impact of introducing an NST, with moderate-grade evidence for the reduction of CRI occurrence compared with standard care. Further, NST introduction significantly reduced metabolic complications, mortality, and inappropriate PN use.

Randomised clinical trial: high-dose oral thiamine versus placebo for chronic fatigue in patients with quiescent inflammatory bowel disease.

BACKGROUND: Fatigue is a burdensome symptom for patients with inflammatory bowel disease (IBD). Few pharmacological interventions have documented effect on fatigue in patients with IBD. A pilot study indicated a 20-day effect  with high-dose thiamine. AIMS: To investigate the effect and safety of high-dose oral thiamine (600-1800 mg/d) based on gender and weight on chronic fatigue in patients with quiescent IBD. METHODS: This was a randomised, double-blinded, placebo-controlled crossover trial. Patients had quiescent IBD, severe chronic fatigue and no other explanation for fatigue. Patients were allocated 1:1 to either 1) high-dose oral thiamine for 4 weeks, 4 weeks of washout, 4 weeks of oral placebo or 2) oral placebo for 4 weeks, 4 weeks of washout, 4 weeks of high-dose oral thiamine. Fatigue was measured using the Inflammatory Bowel Disease-Fatigue Questionnaire. The primary outcome was improvement (≥3 points) of fatigue after 4 weeks on thiamine. RESULTS: Forty patients were enrolled between November 2018 and October 2019. Crossover analysis showed a mean reduction of 4.5 points (95% CI 2.6-6.2) in fatigue after thiamine compared with a mean increase of 0.75 point (95% CI -1.3-2.8; P = 0.0003) after placebo. Furthermore, 55% of group 1 and 75% of group 2 showed an improvement ≥ 3 points while on thiamine compared with 25% of group 1 and 35% of group 2 while on placebo. Only mild side effects were detected. CONCLUSION: We showed a significant beneficial effect of high-dose oral thiamine on chronic fatigue in IBD. The treatment was well tolerated. TRIAL REGISTRATION: NCT03634735.