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NCT07238790 · ClinicalTrials.gov registry record · Early Phase 1
Use of A Complex Gut Bacterial Consortium (MITI 001) for the Treatment of Irritable Bowel Syndrome With Diarrhea
A Early Phase 1 study, sponsored by Stanford University.
- Not yet
- Registry status
- Early Phase 1
- Development phase
- 13
- Enrollment target
NCT07238790: Clinical Trial Early Phase 1 study, sponsored by Stanford University.
NCT07238790 is a Early Phase 1 study that has not yet begun recruiting, run by Stanford University. The registered enrollment target is 13 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07238790, a Early Phase 1 study, has not yet begun recruiting, sponsored by Stanford University.
- NOT YET RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 13 participants
- Enrollment target
Study 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.
Interventions
- DRUG MITI-001 administration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2025-12 |
| Est. Completion | 2030-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07238790
The ClinicalTrials.gov registry entry for NCT07238790 describes a study currently listed as not yet recruiting, categorized as Early Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MITI-001 administration is the first listed.
NCT07238790 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07238790 about?
NCT07238790 is a clinical study titled "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 perpet...
What is the current status of trial NCT07238790?
This trial is currently not yet recruiting. It is a Early Phase 1 study. The enrollment target is 13 participants. The study started on 2025-12. Estimated completion is 2030-12.
What interventions are being tested in trial NCT07238790?
The interventions under investigation include: MITI-001 administration (DRUG).
Who is sponsoring clinical trial NCT07238790?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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