Clinical Research Directory

Specimen and Data Collection for a Novel Biomarker Combination for the Differential Diagnosis of Inflammatory Bowel Disease and Irritable Bowel Syndrome.

This study will evaluate how well the a new stool test can distinguish inflammatory bowel disease (IBD) from non-IBD conditions compared with standard calprotectin testing and colonoscopy findings. Participants will undergo only routine clinical care, including colonoscopy, and will provide a stool sample for testing. The study will also examine how test results relate to endoscopic, histologic, and ultrasound measures of disease activity. Findings may help determine whether the new test could reduce unnecessary colonoscopies and support future regulatory submissions.

Study Evaluating the Efficacy of Different Mixes of HMO-2FL + Humiome® Post LB on IBS Gastrointestinal Symptoms

A randomized, placebo-controlled, double-blind clinical study to evaluate the efficacy of two different mixes of HMO-2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB) on Gastrointestinal Symptoms in individuals with Irritable Bowel Syndrome (IBS)

Lactose Intolerance and Intestinal Permability

"This study evaluates the interplay between lactose intolerance, intestinal barrier function (zonulin), and intestinal inflammation (fecal calprotectin) in adults, aiming to clarify their independent contributions to symptom severity and quality of life."

Lf-rTMS Attenuates Visceral Pain in Irritable Bowel Syndrome With Diarrhea

Objectives: To identify a central hub of visceral pain in IBS-D and elucidate the mechanism by which repetitive transcranial magnetic stimulation (rTMS) confers analgesic effects. Methods: A total of 42 IBS-D patients were recruited and randomly assigned (1:1) to the sham rTMS or the rTMS group. A nested cohort of 21 IBS-D participants who completed baseline fMRI assessments prior to randomization was included. Consistent with the randomization procedure，these individuals were evenly distributed between the two groups. Both participants and outcome assessors remained blinded to treatment allocation throughout the study. All patients completed the two-week intervention and were included in the final analysis.

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.

Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome

This is a double-blind, randomized (group assignment by chance), placebo-controlled, multicenter trial which will be conducted over a 13.5-months period The main objective of the research is to demonstrate the efficacy of Saccharomyces boulardii CNCM I-745 on global IBS symptoms, measured by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS), in comparison to placebo after 8 weeks. Secondary efficacy objectives are to evaluate the impact of Saccharomyces boulardii CNCM I-745 on quality of life of IBS patients and on global and individual IBS symptoms, using the IBS-SSS, in comparison to placebo at regular intervals over a 3-month treatment period. This research also aims to evaluate the proportion of patients who improved ≥ 50 points on IBS-SSS and the proportion of responders according to the European Medicines Agency (EMA) definition (based on the patient's global assessment of efficacy and on abdominal pain score), after 8 weeks of treatment. Secondary safety objective is to evaluate the safety profile and tolerability of Saccharomyces boulardii CNCM I-745 capsules 500 mg/day in IBS patients in comparison to placebo

Efficacy of Rifaximin With NAC in IBS-D

The purpose of this study is to examine the effectiveness of using a combination of a drug, rifaximin and a dietary supplement, N-acetyl-L-cysteine (NAC), to treat patients with irritable bowel syndrome with diarrhea (IBS-D). Rifaximin is one of the standard treatments for IBS-D and is FDA approved. While rifaximin is safe and effective for treating symptoms in patients with IBS-D, many patients find that their symptoms may not completely resolve, or may come back after a period of time. This research study is designed to test the investigational use of a combination of rifaximin and NAC. The combination of rifaximin and NAC is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of IBS-D, and the effects of taking both medications together are unknown. However, the two medications are approved for use separately, as detailed below. Rifaximin is the only antibiotic approved by the FDA for the treatment of IBS-D. Rifaximin (at a dose of 550 mg by mouth three times daily for 14 days) is approved by the FDA for the treatment of IBS-D. Rifaximin (at a dose of 200 mg per mouth three times daily for 3 days) is FDA approved for the treatment of traveler's diarrhea. Rifaximin at a dose of 200 mg per mouth three times daily is not approved by the FDA for the treatment of IBS-D. NAC is approved by the FDA to treat acetaminophen overdose (72-hour oral and 21-hour intravenous (IV) regimens), and for use in breaking up mucus in the lungs in patients with chronic obstructive pulmonary disease (COPD) and other lung conditions such as bronchitis. NAC is also available over-the-counter in 600 mg and 900 mg capsules as a dietary supplement, although over-the-counter use is not regulated by the FDA. This study will utilize the 600 mg dietary supplement capsules. The Investigators want to know if using a combination of rifaximin and NAC will give better results in decreasing IBS-D symptoms than using rifaximin alone. As NAC is used to break up mucus in the lungs, and the Investigators want to see if this can also break up the mucus layer in the small intestine, and therefore potentially increase the effectiveness of rifaximin. The Investigators will be testing 2 doses to determine which dose is most effective. participants are being asked to take part in this research study because participants were diagnosed with IBS-D.

Transcranial Magnetic Stimulation and Pharmacologic/Probiotic Interventions for Diarrhea-Predominant IBS

What is the study about? This study is for adults with diarrhea-predominant irritable bowel syndrome (IBS-D) who suffer from chronic visceral pain. We aim to investigate whether combining two different treatment approaches is more effective in alleviating IBS-D symptoms than either treatment alone. The first treatment is a non-invasive brain stimulation technique called repetitive Transcranial Magnetic Stimulation (rTMS), while the second treatment involves either an intestinal antispasmodic medication (Pinaverium Bromide) or a probiotic (Bifidobacterium). What will participants do? Participants will be randomly assigned by a computer to one of four groups: 1. Group 1: Receive real rTMS sessions + take Pinaverium Bromide pills. 2. Group 2: Receive real rTMS sessions + take Bifidobacterium pills. 3. Group 3: Receive fake (sham) rTMS sessions + take Pinaverium Bromide pills. 4. Group 4: Receive fake (sham) rTMS sessions + take Bifidobacterium pills. Neither the participant nor the doctor giving the treatments will know which group the participant is in for the rTMS part (this is called "blinding"). The study will involve several weeks of treatment and follow-up visits to track symptoms. What are the potential benefits and risks? Potential Benefits: Participants may experience a reduction in their abdominal pain, diarrhea, and other IBS symptoms. However, benefit cannot be guaranteed. The information from this study may help other IBS patients in the future. Potential Risks: rTMS is generally safe but may cause mild headache, scalp discomfort, or lightheadedness. The medications may have side effects like any drug, which will be explained in detail before the study starts. Why is this study important? This is the first study to test how brain stimulation and gut-focused treatments work together for IBS pain. The results could lead to new and more effective combination therapies for people who don't get enough relief from current treatments.