Proteolytic Activity-Guided Fecal Microbiota Transplant for PI-IBS
Official title: Efficacy and Safety of Proteolytic Activity-Guided fecal Microbiota Transplantation for Irritable Bowel Syndrome (PRAGMAT trial)
Funded at Mayo Clinic Rochester · NIH-11377587 · Data updated 2026-11-12
A pilot study will test a targeted fecal microbiota transplant to help adults with post-infection irritable bowel syndrome feel better and have fewer GI symptoms.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Mayo Clinic Rochester NIH-funded |
| Lab location | 1 site (Rochester, United States) |
| Project start | September 1, 2024 |
| Project end | June 30, 2027 |
| Funding year | 2026 |
| Award (this year) | $322,800 |
| NIH project number | 5R01DK137800-03 |
| Project ID | NIH-11377587 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults 21 years and older with post-infection IBS who have high gut proteolytic activity and meet study criteria.
✕Less likely to help
Some participants may not experience symptom improvement or could have no response to the transplant.
What this research studies
This project plans a small, randomized, double-blind, placebo-controlled trial in adults with PI-IBS to see if selecting donors with low proteolytic activity improves symptoms. Participants will receive either a targeted FMT or placebo, with careful monitoring for safety and any adverse events. The study builds on earlier work showing that certain gut microbes can reduce damaging proteases and may restore gut barrier function. If successful, the approach could lead to a personalized microbiome-based treatment for PI-IBS.
Why it matters
Potential benefit: If successful, patients with PI-IBS could experience reduced symptoms and better quality of life through a novel microbiome-based therapy.
How similar studies have gone: Preliminary data in humanized mouse models and PI-IBS patients suggest targeting proteolytic activity can modulate symptoms, though human efficacy is still being tested.
Where this research is happening
-
Mayo Clinic Rochester
Rochester, United States Active
Researchers
- Principal investigator: Grover, Madhusudan — Mayo Clinic Rochester
- Study coordinator: Grover, Madhusudan
Related research
Other NIH-funded projects on the same topics.
-
A new way to use gut bacteria transplants for Irritable Bowel Syndrome
This research explores if a special type of fecal microbiota transplant, guided by specific gut enzyme activity, can safely and effectively improve symptoms for adults with Irritable Bowel Syndrome that developed after an infection.
-
Using targeted fecal microbiota transplantation to treat irritable bowel syndrome
This study is looking at whether a special treatment called fecal microbiota transplantation (FMT) can help people with irritable bowel syndrome (IBS) who started having symptoms after an intestinal infection, by using healthy gut bacteria from carefully chosen donors to improve their gut health.
-
Fecal transplant plus fiber to treat graft-versus-host disease after blood stem cell transplant
A study to see if giving fecal transplant along with dietary fiber helps gut health and reduces complications in patients who have received a stem cell transplant and developed graft-versus-host disease.
-
Fecal microbiota transplantation plus immune checkpoint blockers for solid tumors
This project looks at whether changing gut bacteria with fecal transplants can boost how well cancer treatments called immune checkpoint blockers work in people with solid tumors.
-
Fecal transplant treatment for auto-brewery (gut fermentation) syndrome
This project gives capsule fecal microbiota transplants to adults with auto-brewery syndrome to try to stop their gut from producing alcohol and causing unexplained intoxication.
-
How missing gut bacteria may drive post-infection irritable bowel syndrome
This project aims to restore missing gut bacteria in adults with post-infection IBS to reduce harmful protein‑breaking enzymes that may cause gut damage and symptoms.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.