A Phase 2 interventional study of Donor Fecal Microbiota Transplantation and Autologous Fecal Microbiota Transplantation in Irritable Bowel Syndrome and Diarrhea, sponsored by Madhusudan (Madhu) Grover, MBBS. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Madhusudan (Madhu) Grover, MBBS · Phase 2, Interventional, and Treatment
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.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's planned enrollment of 43 is below the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →This is the only study on the registry with Madhusudan (Madhu) Grover, MBBS as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive a fecal microbiota transplantation (FMT) using stool from a donor
Biological: Donor Fecal Microbiota Transplantation
Subjects will receive a fecal microbiota transplantation (FMT) using their own stool
Biological: Autologous Fecal Microbiota Transplantation
Single fecal microbiota transplantation using 50 gm of freeze-thawed donor stool
Single fecal microbiota transplantation using 50 gm of stool collected from the same individual
Percentage of responders
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.
Time frame: 12 weeks
Change in level of fecal proteolytic activity
The level of fecal proteolytic activity will be measured at baseline and again at 12 weeks. The proteolytic activity is measured using a standardized FITC Casein assay that relies on the activity of proteases in the sample to digest casein protein.
Time frame: Baseline, 12 weeks
Changes in in vivo excretion of 2-24 hr lactulose excretion
Measured by permeability testing
Time frame: Baseline, 12 weeks
Number of weekly responders
Number of subjects to meet responder criteria of ≥30% decrease in average of worst abdominal pain in past 24 hours plus ≥50% decrease in the number of days per week with at least one stool that has a consistency of Type 6 or 7 (compared with baseline)
Time frame: 12 weeks
Global Adequate Relief Questionnaire
Number of subjects to report adequate relief of IBS symptoms, measured by answering yes to question "In the past 7 days have you had adequate relief of your IBS symptoms?"
Time frame: 12 weeks
Alistipes putredinis proportion post-FMT
Number of subject to have the bacteria Alistipes putredinis in stool sample after fecal microbiota transplantation (FMT)
Time frame: 12 weeks
Plan to share: No
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