Fecal Microbiota Transplantation for IBS

Overview

About this study

The purpose of this study is to learn the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity and containing the bacteria Alistipes putredinis in patients with post-infection irritable bowel syndrome (PI-IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

* Campylobacter PI-IBS defined by Rome III or 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 fundoplication, 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/21/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Madhusudan Grover, M.B.B.S.	Open for enrollment	Contact information: Ashley Keehn R.T.(R)(CT) (507) 293-0237 Keehn.Ashley@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Madhusudan Grover, M.B.B.S.

Open for enrollment

Contact information:

Ashley Keehn R.T.(R)(CT)

(507) 293-0237

Keehn.Ashley@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials