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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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (75% lower). 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.
Primary Outcome
Incidence of MITI-001-related adverse events
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 |
What is known before NCT07238790 opens enrollment
NCT07238790 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which MITI-001 administration is the first listed.
NCT07238790 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07238790's enrollment target sits among peer trials
13 1503rd of 2000 higher than 472 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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