Use of A Complex Gut Bacterial Consortium (MITI 001) for the Treatment of Irritable Bowel Syndrom… (NCT07238790) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Use of A Complex Gut Bacterial Consortium (MITI 001) for the Treatment of Irritable Bowel Syndrome With Diarrhea
United States13 participantsStarted 2025-12
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age 18 to 65 years inclusive at the time of signing the informed consent.
✓. Diagnosis of IBS-D according to the Rome IV criteria (Lacy 2017).
✓. At least 1 of the following measures of microbiome dysfunction:
✓. Primary bile acid proportion ≥ 12% in stool samples, or
✓. Positive hydrogen breath test (with either glucose or lactulose substrate) (Rezaie 2017)
✓. Normal C-reactive protein level
✓. Gallbladder intact
✓. Willing to use appropriate contraception during the treatment period and for one week after the last study visit.
Exclusion criteria
✕. Inflammatory bowel disease
✕. Untreated enteric infections
✕
What they're measuring
1
Determine the safety of MITI-001 in the participant population
. History of gastrointestinal (GI) surgery: All participants with GI surgeries below the pylorus will be excluded from this study. This includes participants with a history of colectomy, segmental colonic resection, and small bowel resections.
✕. Documented severe gastroparesis
✕. Active intestinal obstruction
✕. Dysphagia (oropharyngeal, esophageal, functional, or neuromuscular)
✕. History of recurrent aspiration episodes
✕. Any conditions associated with a high risk of bleeding, including but not limited to coagulopathy/bleeding disorder, severe liver disease, active or recent GI bleeding, or recent abdominal or other GI surgery