Clinical Research Directory

Efficacy and Safety of Encapsulated Bifidobacterium Longum BBH016 in Subjects With Lower Gastrointestinal Symptoms

Functional lower gastrointestinal (GI) symptoms such as abdominal pain, diarrhea, loose stools, and bloating are common in adults without identifiable organic disease and are associated with impaired quality of life and increased healthcare utilization. Growing evidence suggests that alterations in the gut microbiota may contribute to the development of these symptoms, supporting the potential role of probiotics as a therapeutic strategy. Bifidobacterium longum BBH016 is a probiotic strain isolated from a healthy donor and classified as Generally Recognized as Safe (GRAS). Preclinical studies have suggested that BBH016 may alleviate abdominal symptoms, reduce intestinal inflammation, and improve gut microbial balance. This investigator-initiated, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of BBH016 capsules in adults with functional lower GI symptoms excluding constipation-predominant presentations. The study will be conducted at Seoul National University Bundang Hospital. A total of 88 participants aged 19-80 years will be randomized in a 1:1 ratio to receive either BBH016 capsules or placebo for 8 weeks (two capsules twice daily). Participants will be assessed at baseline, 4 weeks, and 8 weeks. The primary endpoint is overall improvement in GI symptoms at week 8 compared with baseline between treatment groups. Secondary endpoints include changes in individual symptom scores, IBS Symptom Severity Score (IBS-SSS), IBS Quality of Life (IBS-QoL), stool frequency and form assessed by the Bristol Stool Form Scale, and psychological well-being measured using the Hospital Anxiety and Depression Scale (HADS). Stool samples will also be collected to evaluate changes in the gut microbiome and their association with clinical outcomes.

Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients

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.

Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea

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

Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis

This clinical trial aims to assess the safety and effectiveness of faecal Microbiota Transplantation (FMT) in improving chronic diarrhea symptoms among patients with systemic sclerosis.

Wells and Enteric Disease Transmission

Approximately 40 million people in the US are served by private, and frequently untreated, wells. Our best estimate is that 1.3 million cases of gastrointestinal illnesses (GI) per year are attributed to consuming water from untreated private wells in the US, but in reality, there are no robust epidemiological data that can be used to estimate cases of GI attributable to these sources. We propose the first randomized controlled trial (RCT) to estimate the burden of GI associated with private well water. We will test if household treatment of private well water by ultraviolet light (UV) vs. sham (inactive UV device) decreases the incidence of GI in children under 5. We will also examine the presence of viral, bacterial, and protozoan pathogens in stool and well water from participants. These data will fill a knowledge gap on sporadic GI associated with federally-unregulated private water supplies in the US.

A Post-marketing Observational Study of Oral Cholera Vaccine

Chinese survey data indicate that the incidence rate of diarrhea in the general population ranges from 0.17 to 0.70 episodes per person-year, whereas among children under five years of age, the rate is significantly higher, ranging from 2.50 to 3.38 episodes per person-year. Over recent decades, rapid economic development has contributed substantially to the reduction of mortality associated with infectious diseases. However, emerging challenges-such as increasing antimicrobial resistance and heightened population mobility-have complicated efforts in infectious disease prevention and control. In a phase III clinical trial of the recombinant B subunit/bacterial whole-cell cholera vaccine (enteric-coated capsule), a statistically significant difference was observed in the overall incidence of diarrhea between the vaccinated group (12.9%) and the control group (26.7%) (P \< 0.01). Findings from similar vaccine studies conducted in Sweden have demonstrated cross-protection against diarrhea caused by enterotoxigenic Escherichia coli (ETEC) and other intestinal pathogens. Specifically, the vaccine conferred a 50% protection rate against Salmonella enterica infections, 82% against mixed infections involving ETEC and Salmonella, and 71% against mixed infections involving ETEC and other pathogens. Evidence from relevant studies suggests that the recombinant B subunit/bacterial whole-cell cholera vaccine may offer protective benefits against non-cholera infectious diarrhea. Nevertheless, there remains a paucity of real-world effectiveness data, particularly in pediatric populations who bear a disproportionately high burden of diarrheal disease.

Defining Ileorectal Syndrome: a Prospective Observational Study

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 Auxiliary Effect of Artificial Intelligence in the Detection of Precancerous Lesions in Proximal Colon Cancer

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.

Evaluating a Water Safety Plan Intervention in Ghana

The objective of this study is to evaluate the effects of water safety plans (WSPs) in rural Ghana. The investigators aim to evaluate the effects of WSPs on water supply system infrastructure, water availability and reliability, water quality, consumer perceptions, water service provider management and financial sustainability, climate resilience, equity, and consumer health.

Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator

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.

Gut Microbiota and Diarrhea in Breast Cancer Patients Receiving Pyrotinib

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.

A Study of SER-155 to Treat Diarrhea in People on Immunotherapy

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.

Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)

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.

Use of A Complex Gut Bacterial Consortium (MITI 001) for the Treatment of Irritable Bowel Syndrome With Diarrhea

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.

First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults

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

Radicle GI Health RDH™: A Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes

A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes

FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis

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.

Fecal Microbiota Transplantation for IBS

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.

GI Alpha-Gal Study

This is a double-blind, crossover food challenge study using pork with and without α-gal in patients with a clinical diagnosis of gastrointestinal (GI)- α-gal allergy, and to investigate the pathophysiology underlying their symptoms.

Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae

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.

Effect of Use of Probiotics on Systemic Infection in Critically Ill Patients: a Double Blind, Randomized, Placebo-controlled Trial

The primary goal of this study is to assess the benefit of probiotics in preventing or minimizing of various type of systemic infection in critically ill adult patients.

Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)

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?"

Enabling Microbiomics- Driven Personalized Nutrition

The goal of this observational research study is to determine how diet contributes to various gastrointestinal related conditions. The main question investigators aim to answer is: Are host genetics, diet, and microbiome all important determinants of GI disorders, and how their relative contribution varies among individuals and populations.

Impact of Probiotics on Antibiotic-associated Diarrhea in Community-acquired Pneumonia

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.