NCT05776914 · Madhusudan (Madhu) Grover, MBBS
Fecal Microbiota Transplantation for IBS
What this study is about
The purpose of this study is to learn the effectiveness 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.
View original scientific description
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.
Interventions
BIOLOGICAL
Donor Fecal Microbiota Transplantation
Single fecal microbiota transplantation using 50 gm of freeze-thawed donor stool
BIOLOGICAL
Autologous Fecal Microbiota Transplantation
Single fecal microbiota transplantation using 50 gm of stool collected from the same individual
Primary outcome measures
Percentage of responders
Time frame: 12 weeks
Number of subjects receiving the donor fecal microbiota transplantation identified as a responder defined as a decrease of ≥50 points in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) from baseline. The Irritable Bowel Syndrome Symptom Severity Score scale has a possible range of scores from 0-500. Mild cases are classified as a score of 75-175, moderate cases are classified as a score of 175-300, and severe cases are classified as a score of \>300.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- IBS defined by Rome IV criteria
- 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
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2026 · Source of record for eligibility and locations