A Phase 1 Study to Evaluate the Safety of a Complex Gut Bacterial Consortium (MITI 001) for the Treatment of Irritable Bowel Syndrome With Diarrhea
Stanford University
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.
Description
MITI-001 has not yet been tested in humans. However, several RCTs support the role of the gut microbiome in IBS-D pathogenesis. These include trials involving non-absorbable antibiotics (e.g., rifaximin) and low-fermentation diets (Ford 2018; Black 2022), which have demonstrated symptom improvement. FMT has also shown promising efficacy in IBS-D (El-Salhy 2020), particularly when pre-treatment with antibiotics and/or bowel lavage was used to deplete the resident microbiota (Ianiro 2022; Zhang 2024). These findings highlight the need for introduction of a complete microbial ecosystem, rather th…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18 to 65 years inclusive at the time of signing the informed consent. 2. Diagnosis of IBS-D according to the Rome IV criteria (Lacy 2017). 3. At least 1 of the following measures of microbiome dysfunction: 1. Primary bile acid proportion ≥ 12% in stool samples, or 2. Positive hydrogen breath test (with either glucose or lactulose substrate) (Rezaie 2017) 4. Normal C-reactive protein level 5. Gallbladder intact 6. Willing to use appropriate contraception during the treatment period and for one week after the last study visit. * Male participants with partn…
Interventions
- DrugMITI-001 administration
A complex gut bacterial community (MITI-001) will be given endoscopically and orally
Locations (2)
- Stanford Digestive Health ClinicRedwood City, California
- Stanford UniversityStanford, California