Fecal Microbiota Transplantation for IBS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2026-12-31

Brief Summary

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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 irritable bowel syndrome (IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Donor Fecal Microbiota Transplantation Group

Subjects will receive a fecal microbiota transplantation (FMT) using stool from a donor

Group Type EXPERIMENTAL

Donor Fecal Microbiota Transplantation

Intervention Type BIOLOGICAL

Single fecal microbiota transplantation using 50 gm of freeze-thawed donor stool

Autologous Fecal Microbiota Transplantation Group

Subjects will receive a fecal microbiota transplantation (FMT) using their own stool

Group Type PLACEBO_COMPARATOR

Autologous Fecal Microbiota Transplantation

Intervention Type BIOLOGICAL

Single fecal microbiota transplantation using 50 gm of stool collected from the same individual

Interventions

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Donor Fecal Microbiota Transplantation

Single fecal microbiota transplantation using 50 gm of freeze-thawed donor stool

Intervention Type BIOLOGICAL

Autologous Fecal Microbiota Transplantation

Single fecal microbiota transplantation using 50 gm of stool collected from the same individual

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No