Diarrhea

The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo. The study will last approximately 36 weeks.

This trial studies how well fecal microbiota transplantation works in treating diarrhea or colitis (inflammation of the intestines) that is caused by certain types of medications (called immune-checkpoint inhibitors) in patients with genitourinary cancer. Fecal microbiota transplantation may effectively reduce the incidence of immune checkpoint inhibitor-induced diarrhea/colitis.

Karamoja, in north-eastern Uganda, is among the most water-insecure regions in sub-Saharan Africa. Only 24 per cent of households can access the WHO-recommended 20 litres of water per person per day. Only 11.7 per cent have access to improved sanitation. A rapid vulnerability assessment covered all 182 operational primary schools in the sub-region between October and November 2025. It identified 53 schools as severely water insecure and a further 37 as moderately water insecure. Together, these schools serve an estimated 196,000 learners. The assessment also found that 89 schools lacked enough latrines to meet the national pupil-to-latrine ratio. Seventy-eight schools had no functional menstrual health management facilities. This study is a three-arm, phase-in cluster-randomised controlled trial. It evaluates the causal effects of a climate-resilient school WASH package on children's health and school attendance. It also examines adolescent girls' menstrual health self-efficacy. The study covers 60 primary schools that were found to be water-insecure across Karamoja's nine districts. The schools were stratified into three geographic zones. The researchers then used covariate-constrained randomisation to assign schools to three study arms. Phase 1 includes 30 schools receiving the intervention early. Phase 2 includes 20 schools receiving it later. The remaining 10 schools form the pure control group. The intervention combines climate-resilient WASH infrastructure with capacity-building and social and behaviour change activities. The infrastructure includes motorised boreholes, sex-disaggregated latrines and handwashing stations built to national standards. A subset of the boreholes will have data loggers for remote monitoring. The package also provides dedicated menstrual health facilities. These include enclosed changing areas and hygienic waste-disposal systems. Community water access points will be installed next to each school. Capacity-building activities will involve School Management Committees, Parent-Teacher Associations, teachers, District Water Officers and School Health Clubs. Data will be collected through three repeated cross-sectional rounds. The baseline will take place in the fourth quarter of 2026. The midline will take place in the first quarter of 2028, and the endline in the first quarter of 2030. Seven instruments will be used. These include pupil and matched caregiver surveys, school WASH facility and classroom roll-call observations, and head teacher and teacher surveys. The study will also digitise school enrolment, attendance and examination records. Community leaders will be interviewed separately. In each round, the sample will include 20 post-menarche girls and 20 general pupils per school. The study will interview one caregiver for each sampled pupil. The study will also interview six teachers, the head teacher and four community leaders in each school catchment. The study has three co-primary outcomes. The first is the pupil absence rate, measured using digitised attendance registers. The second is the seven-day prevalence of diarrhoea among pupils. The third is menstrual health self-efficacy among post-menarche girls. We will measure this using the 26-item Self-Efficacy in Addressing Menstrual Needs Scale (SAMNS-26). The primary analysis will estimate the intent-to-treat effect of assignment to Phase 1. At midline, Phase 1 schools will be compared with Phase 2 and pure control schools. We will conduct two comparisons at endline. First, we will compare all treated schools with the pure control group. Second, Phase 1 schools will be compared with Phase 2 schools to test whether effects differ by exposure duration.

The goal of this intervention trial is to learn if the use of drinking water filters will result in improved health outcomes for people living in homes with well water and spring water in rural regions of Central Appalachia.

The purpose of this study is to assess the prevention of immune checkpoint inhibitors (ICI) related diarrhea/colitis using vedolizumab in participants with unresectable stage III or metastatic stage IV cancer, starting standard of care (SOC) immunotherapy

The goal of this clinical trial is to learn how rifaximin 200 mg is processed in the body (pharmacokinetics) in children 6 to 11 years old with acute diarrhea that may be caused by bacteria. It will also learn about the safety and effectiveness of rifaximin when given with oral rehydration therapy (ORT) compared with ORT alone. The main questions it aims to answer are: How does rifaximin 200 mg move through and leave the body in children with acute diarrhea? Is rifaximin safe for children in this age group? Does rifaximin plus ORT help resolve diarrhea faster than ORT alone? Researchers will compare rifaximin plus ORT to ORT alone to see if adding rifaximin improves outcomes. Participants will: Take one rifaximin 200 mg tablet + ORT three times a day for 3 days or receive ORT alone Receive oral rehydration therapy according to the investigator's standard of care Attend up to 4 clinic visits over 5 days and receive 4 follow-up phone calls Provide blood samples on Day 1 and Day 3 for pharmacokinetic testing (rifaximin group only) Provide stool samples to identify bacterial pathogens Keep a diary of stool frequency and consistency to help determine when diarrhea resolves Be monitored for side effects, vital signs, and laboratory changes

This prospective, interventional, single-center, open-label, phase 1 clinical trial to assess the safety of the Postbiotic Lactobacillus LB in immunocompromised paediatric patients with diarrhoeal disease will be performed at Federico Gomez Children's Hospital of México. Patients will be screened by investigators from hospitalized patients. For eligible children, parents will be invited to participate in the study and provide written consent, in patients of age 8 years and older, informed assent will also be required. Once enrolled, patients' demographic and stratification information will be obtained from the clinical record when applicable, if not, it will be directly collected by the investigator. Patients who have immunocompromise, as per investigator assessment, irrespective of the cause, will receive Lactobacillus LB (Lactéol®) sachets twice daily for 14 days for patients with acute diarrhoeal disease (\<72 hours of onset) and for 28 days for patients with chronic diarrhoea (≥15 days). Patients will continue follow-up while receiving treatment in hospital, whereas patients who are discharged during the treatment period will continue follow-up via phone calls once weekly and a final evaluation of outcome variables in outpatient clinic at the end of the intervention. Data regarding adverse events, as well as the stop of diarrhoea (\<3 bowel movements in 24 hours or return to habitual bowel movement frequency) and improvement in stool consistency (at least one point decrease in Bristol Stool Scale) will be collected in every evaluation. Afterwards, the presence or absence of adverse events will be established with a binomial test. As efficacy evaluation is not the main objective of the study, efficacy will be assessed as exploratory variables as presence or absence of efficacy endpoints with the binomial test. If feasible, results may be stratified according to nutritional status, time of onset of diarrhoea, and treatment compliance.

The purpose of this study is to find out whether SER-155 may be a safe first treatment that causes few or mild side effects for people due to irEC.

Background: Pyrotinib is an effective targeted drug for HER2-positive breast cancer, but it very frequently causes diarrhea, which can be severe enough to disrupt treatment and reduce patients' quality of life. The reason why some patients develop diarrhea while others do not is not well understood. Recent research suggests that the community of bacteria in the gut (gut microbiota) may play a key role in this side effect. What is the purpose of this study? This is an observational study (Phase 1) that aims to understand the relationship between pyrotinib treatment, changes in gut bacteria, and the occurrence of diarrhea. The main goal is to compare the gut bacteria of patients who develop diarrhea while taking pyrotinib with those who do not. Researchers hope to identify specific bacteria that might protect against diarrhea, which could lead to new ways to prevent or treat this side effect in the future. What will happen in the study? Patients with HER2-positive breast cancer who are being treated with pyrotinib will be invited to participate. They will be divided into two groups: those who experience diarrhea and those who do not. Participants will provide stool samples at specific time points (e.g., 2 and 4 weeks after starting pyrotinib). They will also allow researchers to collect information from their medical records about their clinical condition and diarrhea symptoms. No experimental intervention will be administered in this phase of the study; all patients will receive standard medical care. Potential Benefits: Participants will not receive any direct benefit from this observational phase of the study. However, the information gathered may help scientists better understand pyrotinib-induced diarrhea and develop future strategies to help other breast cancer patients manage this side effect more effectively.

Enteral nutrition-associated diarrhea (ENAD) is one of the most common gastrointestinal complications in critically ill patients receiving enteral nutrition, with a reported incidence of 22.3%-63.1%. Current management lacks a standardized nursing process and relies on individual nurse experience. This study constructs a standardized nursing care pathway driven by the Bristol Stool Form Scale (BSFS) and evaluates, in a prospective randomized controlled design, whether it reduces the severity of ENAD compared with routine ICU care. Eligible mechanically fed ICU patients are randomized 1:1 to the care-pathway group or the routine-care group, observed for 7 days (D1-D7) with a follow-up assessment on D14. The primary endpoint is the Hart diarrhea score over the observation period.

Prospective observational cohort study evaluating the early proctologic effects of GLP-1 receptor agonist therapy in morbidly obese patients. Participants will undergo baseline and 3-month anorectal symptom assessment and proctologic examination to evaluate newly developed proctologic diseases and changes in pre-existing symptoms.

Acute gastroenteritis (AGE) is among the most common reasons for paediatric emergency visits. Children with significant dehydration often require intravenous (IV) fluid therapy. Two main types of IV crystalloid solutions are currently used in clinical practice: 0.9% sodium chloride (normal saline, NS) and balanced crystalloids such as Isolyte-S, which contain acetate and gluconate as bicarbonate precursors. Normal saline has a high chloride content (154 mEq/L), which may worsen the metabolic acidosis already present in many children with acute gastroenteritis. Balanced crystalloids have a chloride content closer to that of plasma (98 mEq/L) and additionally contain acetate and gluconate, which are metabolised in peripheral tissues to consume hydrogen ions and thereby raise serum bicarbonate - a mechanism distinct from simply avoiding chloride overload. This study prospectively observes and compares early biochemical and clinical outcomes in children with acute gastroenteritis who receive one of these two fluid types as part of their routine clinical care. The treating physician independently decides which fluid to use; the research team does not influence this decision and does not order any additional tests or procedures. Laboratory values used as outcomes are drawn solely from blood tests obtained as part of standard care. The primary aim is to determine whether, at approximately 4 hours after IV fluid start, serum bicarbonate has changed more in children who received a balanced crystalloid compared with those who received normal saline. Secondary aims include comparing blood pH, chloride levels, need for additional IV boluses, time to first oral fluid intake, hospitalisation rate, and 72-hour return visits.

This study evaluates the implementation and effectiveness of in-line chlorination (ILC) for improving drinking water quality in rural Nigeria. Unsafe drinking water remains a major contributor to diarrheal disease, particularly among children under five. Inline chlorination is a passive water treatment approach that automatically doses chlorine at community water systems without requiring electricity or daily user action. Two cluster randomized controlled trials will be conducted in Kano State (North-West Nigeria) and Cross River State (South-South Nigeria). Communities will be randomized to either receive in-line chlorination installed at eligible communal water systems or serve as controls with no chlorination. The unit of randomization is a community or a cluster of communities that share water system for drinking water. The primary objective is to estimate the causal impact of in-line chlorination on household drinking water quality. Outcomes include the prevalence of Escherichia coli contamination in tap water and stored household water as well as the presence of free chlorine residual. Secondary objectives assess water source usage and adoption of chlorinated sources, as well as reduction in diarrheal disease. Implementation fidelity and operational performance of chlorination devices will also be monitored.

The purpose of this study is to learn the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity and containing the bacteria Alistipes putredinis in patients with irritable bowel syndrome (IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.

The goal of this clinical trial is to learn if a conditional social transfer works to improve rates of complementary breastfeeding. It will also learn about the impacts of social transfers on maternal and child health and development. The main questions it aims to answer are: * Does the social transfer increase complementary breastfeeding rates at 24-months postpartum? * Does the social transfer increase complementary breastfeeding duration? * Does the social transfer impact child health and development? * Does the social transfer impact maternal physical and mental health? Researchers will compare a conditional social transfer to a control group that only receives education about breastfeeding recommendations to see if a conditional social transfers works to increase complementary breastfeeding. Participants will: Receive a pamphlet explaining the current recommendations of breastfeeding Receive instructions that if they meet the recommendation to breastfeed until 24-months postpartum they receive a social transfer or receive no additional information Complete home visits at 12- and 24-months postpartum Complete detailed questionnaire

1. Study Title: Trying to Define Ilorectal Syndrome: A Prospective Observational Study 2. Study Objective and Significance: Primary Objective: To prospectively evaluate the frequency, symptom severity, and impact on quality of life of ileorectal syndrome developing in patients who have undergone total colectomy and ileorectal anastomosis. Secondary Objectives: * To examine the relationship between postoperative bowel dysfunction and quality of life * To investigate clinical factors affecting symptom severity This study aims to contribute to postoperative follow-up and management strategies by revealing patient-centered outcomes of ileorectal syndrome. 3. Expected Benefits and Risks of the Study: Expected Benefits * Prospective and systematic evaluation of ileorectal syndrome * Identification of factors affecting the quality of life of these patients * Increased awareness in clinical follow-up Potential Risks * The study is observational and questionnaire-based and does not involve additional medical risks * No invasive procedures will be performed on the patients 4. Type, scope, and design of the planned study: * Type: Prospective, observational * Scope: Single-center * Design: Questionnaire-based clinical trial 5. Number of patients and volunteers to be included in the study, their qualifications, and the rationale for selection: * Total number of patients: 30 * Age range: ≥18 years * Gender: Female and male This number was determined based on the appropriate patient population followed in our center. 6. Parameters to be examined: Demographic data (age, gender, BMI) Surgical indication Whether the surgery was performed openly or laparoscopically Level of anastomosis Maximum daily bowel movement frequency and duration Feeling of urgency Nocturnal bowel movements Fluid/gas incontinence - soiling Ileus in ADBG Whether electrolyte abnormalities developed Length of hospital stay Need for re-hospitalization Severity of symptoms based on patient reports and questionnaire questions 7. Where and by whom the parameters will be examined Data will be collected by the responsible investigator at the relevant clinic. 8. Which parameters to be used in the study are routine for that disease group and which are specific to the study? Routine: Demographic data, surgical information, laboratory results Study-Specific: Postoperative bowel functionality, symptom questionnaire 9. Estimated study duration, start and end dates: Start date: 1/1/2026 End date: 31/12/2026 Total duration: 12 months 10. Inclusion, exclusion, and withdrawal criteria: Inclusion Criteria * Having undergone total colectomy and ileorectal anastomosis * 18 years of age and older * Providing written informed consent Exclusion Criteria * Serious neurological disease affecting bowel function * Patients with incomplete follow-up data Withdrawal * At the patient's request * If follow-up cannot be completed 11. Termination criteria: By the ethics committee Termination decision Unforeseen circumstances preventing the conduct of the study 12. Statistical methods to be used in the evaluation of the data to be obtained as a result of the research: * Descriptive statistics (mean, median, percentage) * Parametric and non-parametric tests * Analysis of the relationship between symptom severity and quality of life * p \< 0.05 statistical significance level

The investigators conducted a multicenter randomized controlled trial to explore the adjuvant effect of artificial intelligence in the detection of precancerous lesions in the proximal colon.This is a prospective, multicenter, single-blind, parallel randomized controlled trial.During the colonoscopy retraction process, the investigators aimed to compare the detection rates of proximal colon adenomas with and without the assistance of an AI(Artificial Intelligence) diagnostic device.

The purpose of this research is to study the added benefit of treating IBS symptoms with a medication called mirtazapine in treating IBS symptoms when paired with a low-FODMAP diet compared to a low-FODMAP diet alone. FODMAP stands for fermentable oligosaccharides, disaccharides, monosaccharides, and polyols. These are short-chain carbohydrates that can cause digestive distress in some people. You have been asked to take part in this research because you have symptoms of diarrhea-predominant irritable bowel syndrome that may respond to treatment with a combination of a medication called mirtazapine and a low-FODMAP diet.

Objective: The investigators objective is to develop and evaluate the effectiveness of a case area targeted water, sanitation, and hygiene (WASH) intervention in reducing cholera infections and increasing sustained WASH behaviors in transmission hotspots in a ring around cholera cases.

Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults

While the pathophysiology of diarrhea-predominant irritable bowel syndrome (IBS-D) is complex and heterogeneous, dysbiosis of the gut microbiome is frequently observed, suggesting that a substantial subset of patients with irritable bowel syndrome (IBS) have symptoms that are initiated and/or perpetuated by a microbiome dysfunction. Successful randomized controlled trials (RCT) for IBS-D (Ford 2018; Black 2022) leveraging microbiome-targeted therapies (antibiotics or low microbiome fermentation diets) suggest the gut microbiome is at least partially involved in IBS symptoms. Furthermore, fecal microbiota transplantation (FMT) for patients with IBS-D has demonstrated promising results (El-Salhy 2020), supporting the possibility that altering the microbiome composition could ameliorate IBS-D symptoms. MITI-001 is a transplantable gut bacterial community composed of 157 live bacterial strains, encompassing 79 genera of commensal bacteria, that have been isolated from healthy donor stool, purified, and banked. The hypothesis of the proposed research is that MITI-001 can target the pathophysiologic lesion in a subset of IBS-D patients, restore the altered microbial metabolic process, and thus alleviate IBS-D symptoms.

The goal of this clinical trial is to determine the outcome of patients with immune checkpoint inhibitor-mediated diarrhea/colitis (IMC) treated with faecal microbiota transplantation (FMT) in a randomised, placebo-controlled trial. The aim of the present study is to assess the feasibility, pilot efficacy, and safety of FMT for patients with IMC. Participants will be treated two times with capsule FMT or placebo capsules in a 1:1 ratio. The intervention treatment will be an add-on to the patients' standard treatment for IMC. Researchers will compare the FMT-treated group to the placebo-treated group to see if FMT promotes remission of IMC.

Children in low- and middle-income countries who are hospitalized for diarrhea and also have malnutrition are at high risk for illness and death in the 6 months period following treatment for diarrhoea despite receiving current guideline recommended diarrhea management (such as oral rehydration solution, or "ORS"). This study will test whether nutritional supplements made from milk (lactoferrin or lysozyme) or a combination of the two (lactoferrin and lysozyme) will prevent children from having repeated diarrhea episodes and help improve their nutrition by improving their stomach health or preventing new disease during this 6-month period. The study is taking place at 7 hospitals in Western Kenya. Six hundred participants will be enrolled if they provide informed consent to participate, are aged 6-24 months, were hospitalized with diarrhea and malnutrition and have been managed by the facility nutritionists and ready to return home. Participation in the study will entail providing information on the child's health history, collection of stool samples, blood, and potentially urine. The caregiver will be provided sachets of the investigational product to take home and mix daily with their child's porridge or other complimentary food, and asked to return to the clinic 4 times in the subsequent 6 months, and also consent to having a community health worker visit their home every two weeks for a follow up visit. The risks to the participant and their caregiver are minimal. The information gained in this study will help us create new treatments and develop new strategies to treat sick children to prevent death and illness.

The study team's principal interest is to address the question, "Will prophylactic treatment with mesalamine reduce the incidence and severity of immune-related diarrhea occurring secondarily to treatment with ipi/nivo?"

The study goal is to determine whether oral administration of a probiotic mixture can reduce the incidence of antibiotic-associated diarrhea in patients with community-acquired pneumonia.