Irritable Bowel SyndromePhase 2NCT05776914
Fecal Microbiota Transplantation for IBS
A Phase 2 study testing Donor Fecal Microbiota Transplantation and Autologous Fecal Microbiota Transplantation in people with Irritable Bowel Syndrome and Diarrhea, run by Madhusudan (Madhu) Grover, MBBS at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome, Diarrhea
- What is being tested?
- Donor Fecal Microbiota Transplantation and Autologous Fecal Microbiota Transplantation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 26 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Minnesota
Rochester, Minnesota, 55905
About this study
Official title: Efficacy and Safety of Proteolytic Activity-Guided Fecal Microbiota Transplantation for Irritable Bowel Syndrome (PRAGMAT Trial)
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.
- Conditions
- Irritable Bowel Syndrome, Diarrhea
- Being tested
- Donor Fecal Microbiota Transplantation, Autologous Fecal Microbiota Transplantation
- Keywords
- Post-infection irritable bowel syndrome with diarrheal, Post-infection irritable bowel syndrome with mixed symptoms
- Medical subject headings
- Irritable Bowel Syndrome, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donor Fecal Microbiota TransplantationBiological
Single fecal microbiota transplantation using 50 gm of freeze-thawed donor stool
Autologous Fecal Microbiota TransplantationBiological
Single fecal microbiota transplantation using 50 gm of stool collected from the same individual
| Study group | Role | What they receive |
|---|---|---|
| Donor Fecal Microbiota Transplantation Group | Experimental | Subjects will receive a fecal microbiota transplantation (FMT) using stool from a donor Receives: Biological: Donor Fecal Microbiota Transplantation |
| Autologous Fecal Microbiota Transplantation Group | Placebo comparator | Subjects will receive a fecal microbiota transplantation (FMT) using their own stool Receives: Biological: Autologous Fecal Microbiota Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: Baseline, 12 weeks
Changes in in vivo excretion of 2-24 hr lactulose excretion
Measured by permeability testing
Measured: 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)
Measured: 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?"
Measured: 12 weeks
Alistipes putredinis proportion post-FMT
Number of subject to have the bacteria Alistipes putredinis in stool sample after fecal microbiota transplantation (FMT)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start15 Apr 2024
- Primary completion26 Jun 2027 (estimated)
- Study completion26 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Madhusudan (Madhu) Grover, MBBS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Madhusudan (Madhu) Grover, MBBS, Mayo Clinic
- Investigators
- Madhusudan Grover, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776914
- Sponsor's protocol ID
- 22-005385
- Status last verified
- May 2026
- First submitted
- 1 Mar 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Proteolytic Activity-Guided Fecal Microbiota Transplantation for Irritable Bowel Syndrome (PRAGMAT Trial)
- ClinicalTrials.gov ID
- NCT05776914
- Acronym / sponsor ID
- 22-005385
- Conditions
- Irritable Bowel Syndrome, Diarrhea
- Keywords
- Post-infection irritable bowel syndrome with diarrheal, Post-infection irritable bowel syndrome with mixed symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Madhusudan (Madhu) Grover, MBBSUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 26 Jun 2027 (estimated)
- Study completion
- 26 Jun 2027 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donor Fecal Microbiota Transplantation Group | Experimental | Biological: Donor Fecal Microbiota TransplantationSubjects will receive a fecal microbiota transplantation (FMT) using stool from a donor |
| Autologous Fecal Microbiota Transplantation Group | Placebo comparator | Biological: Autologous Fecal Microbiota TransplantationSubjects will receive a fecal microbiota transplantation (FMT) using their own stool |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donor Fecal Microbiota TransplantationSingle fecal microbiota transplantation using 50 gm of freeze-thawed donor stool | Biological | Donor Fecal Microbiota Transplantation Group |
| Autologous Fecal Microbiota TransplantationSingle fecal microbiota transplantation using 50 gm of stool collected from the same individual | Biological | Autologous Fecal Microbiota Transplantation Group |
Primary outcome
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.
5 secondary outcomes
Change in level of fecal proteolytic activity
Time frame: Baseline, 12 weeks
Changes in in vivo excretion of 2-24 hr lactulose excretion
Time frame: Baseline, 12 weeks
Number of weekly responders
Time frame: 12 weeks
Global Adequate Relief Questionnaire
Time frame: 12 weeks
Alistipes putredinis proportion post-FMT
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Madhusudan Grover, MBBS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Donor Fecal Microbiota Transplantation and Autologous Fecal Microbiota Transplantation in people with Irritable Bowel Syndrome and Diarrhea, run by Madhusudan (Madhu) Grover, MBBS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonah Pedelty, MS (507-538-7774, pedelty.jonah@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of responders (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.