Fecal microbiota transplantation for treating irritable bowel syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity, specifically targeting patients with irritable bowel syndrome (IBS) characterized by high proteolytic activity. Participants will undergo either donor or autologous FMT to assess improvements in their IBS symptoms. The study focuses on individuals with moderate to severe symptoms as defined by established criteria. The approach seeks to restore a healthy gut microbiome to alleviate IBS symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* IBS defined by Rome IV criteria
* Non IBS-C
* Moderate to severe symptoms defined by IBS-SSS≥175
* Able to safely undergo and consent to colonoscopy

Exclusion Criteria

* Immune deficiency or treatment with immunosuppressive medications
* Severe bowel or medical disease precluding administration of bowel prep
* Severe bowel or medical disease precluding colonoscopy with conscious sedation
* Active cancer
* Pregnant or lactating
* Abdominal surgery (exception of splenectomy, partial hepatectomy, partial/unilateral nephrectomy, laparoscopy, pelvic floor repair, mesh, liposuction, fundoplication, tubal ligation, gastric sleeve, oophorectomy, hernia, appendectomy, cholecystectomy, caesarean section and hysterectomy)
* Severe psychiatric disorder (HADS-A or D\>16), or diagnosed alcohol or drug abuse disorder
* New probiotics or treatment with antibiotics, NSAIDs (within 4 wks prior to study entry)
* Use of treatments known to affect colonic motility (with exception of loperamide)
* Diagnosed h/o bleeding disorder
* Organic GI diseases (IBD, celiac disease, microscopic colitis)
* Chronic kidney or liver disease
* Absolute neutrophil count (ANC) \<500 IU/ml

Where it's running

• Mayo Clinic in Minnesota
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Madhusudan Grover, MBBS — Mayo Clinic
• Study coordinator: Jonah Pedelty, MS
• Email: pedelty.jonah@mayo.edu
• Phone: 507-538-7774

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Brenipatide (LY3537031) treatment for adults with IBS‑D

  This will test whether brenipatide (LY3537031) given under the skin helps adults with IBS‑D reduce belly pain and improve stool consistency compared with placebo.

  Recruiting at 80 sites Phase 2 Eli Lilly and Company · Mesa, Arizona and 88 other locations · NCT07545759

• Gut health follow-along with Peachbiotic in adults

  This single-arm study tests whether Peachbiotic taken daily for 12 weeks helps adults with gut symptoms feel better.

  Recruiting Peach Perfect · Las Vegas, Nevada · NCT07927907

• Impact of a climate-resilient WASH package in Karamoja schools

  This study tests a climate-resilient water, sanitation and hygiene package in severely water-insecure primary schools in Karamoja to see if it reduces diarrhea and respiratory infections and improves attendance, especially among girls.

  Recruiting Unicef · Moroto · NCT07823231

• Do home water filters improve health for people with private wells in rural Central Appalachia

  This study tests whether providing point-of-use water filters to households using well or spring water in rural Central Appalachia can reduce acute gastrointestinal illness.

  Recruiting Virginia Polytechnic Institute and State University · Johnson City, Tennessee and 1 other locations · NCT07818902

• Liver Fat and Scarring in People Suspected of Non-Celiac Wheat Sensitivity

  This study looks to see if people with non-celiac wheat sensitivity have liver fat or fibrosis and how this relates to IBS/FD and celiac disease.

  Recruiting at 2 sites University of Palermo · Palermo, Palermo and 1 other locations · NCT07750535

• Balanced IV Fluids for Kids with Acute Gastroenteritis

  This study compares balanced crystalloids versus normal saline for IV hydration in young children with acute gastroenteritis to see if it improves acid–base status and clinical outcomes.

  Recruiting Aydin Adnan Menderes University · Aydin · NCT07610382

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.