Ulcerative ColitisPhase 2MINDFULNCT03998488
Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis
A Phase 2 study testing Fecal Microbiota Transplantation and Psyllium Husk Powder in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
A double-blind, randomized, placebo-controlled clinical trial examining the efficacy and safety of Fecal Microbiota Transplantation (FMT) and high fiber supplementation in patients with active mild to moderate Ulcerative Colitis (UC). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Diseases
- What is being tested?
- Fecal Microbiota Transplantation and Psyllium Husk Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2020to 12 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female ≥ 18 years of age.
- Documentation of prior history of mild to moderate UC.
- Endoscopy confirmed active UC ≥ 15 centimeters at week 0 screening colonoscopy.
- As defined by a total Mayo scoring of 4-10 with an endoscopic sub-score ≥ 1.
- Patients must have a descending intact colon.
- Patients taking steroid or biologic therapy must be on a stable dose for 4 weeks prior to screening and maintained throughout the trial.
Show all 11Show fewer
- Eligible patients willing to undergo screening testing prior to FMT to document baseline status:
- Urine Testing
- Blood Testing
- Stool Testing
- Patients must discontinue anti-rCDI antibiotics (e.g. vancomycin, fidaxomicin) 48 hours prior to FMT delivery procedure.
Who cannot join
- Biopsy proven Crohn's disease
- UC patients with severe disease (defined as a total mayo score >10)
- Clinical complications requiring emergent management (e.g. stricture, bowel obstruction, perforation and/or abscess)
- Concurrent C. difficile or other infections
- Primary sclerosing cholangitis
- Prior history of FMT
Show all 13Show fewer
- Treatment for malignancy within past 5 years
- Active or latent tuberculosis
- Clinically meaningful laboratory abnormalities
- Hb: < 8
- ALT: greater than 3x the ULN (upper limit of normal)
- History of anaphylactic reactions to food allergens or allergy to psyllium husk
- Subject having any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the subject participating in the study, would make it unlikely for the subject to complete the study, or would confound the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled Clinical Trial Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Subsequent Dietary Fiber in Patients With Moderate Ulcerative Colitis
A double-blind, randomized, placebo-controlled clinical trial examining the efficacy and safety of Fecal Microbiota Transplantation (FMT) and high fiber supplementation in patients with active mild to moderate Ulcerative Colitis (UC). All enrolled subjects will provide serological, stool and mucosal specimen at each clinic visit to help further define the alterations in microbial profiles and immune cell function in response to psyllium fiber after FMT treatment.
Read the detailed description
This is a randomized, double-blind, placebo-controlled clinical trial with the following treatment assignments:
- Investigational FMT (one-time)
- Subject will blindly receive investigational FMT once at day 0 colonoscopy
- Subjects in this group will blindly receive placebo FMP250 at week 8 by flexible sigmoidoscopy.
- Investigational FMT (one-time) + Psyllium (2x/day for 8 weeks)
- Subject will blindly receive investigational FMT once at day 0 colonoscopy
- Subjects in this group will blindly receive placebo FMP250 at week 8 by flexible sigmoidoscopy.
- Placebo FMT (one-time) +/- Psyllium (2x/day for 8 weeks)
- Subject will blindly receive placebo FMT once at day 0 colonoscopy
- Subjects in this group will blindly receive investigational FMP250 at week 8 by flexible sigmoidoscopy.
Subjects will blindly receive the investigational or placebo FMP250 treatment if they meet all inclusion and exclusion criteria during the day 0 screening colonoscopy. Subjects will receive follow-up phone calls at day 1, week 2, week 6, and week 10 post-FMT and will return for clinic visits at week 4, week 8 and week 12 post-FMT. Stool and blood samples will be collected for research purposes from subjects at every clinic visit (Day 0 colonoscopy, Week 4, Week 8, and Week 12). Mucosal biopsies will also be taken during the initial colonoscopy, at day 0 and during the follow-up flexible sigmoidoscopy at week 8. At week 8 post-FMT, all subjects will be evaluated by flexible sigmoidoscopy. Subjects originally randomized into the placebo cohort at week 0 will receive investigational FMP250 by flexible sigmoidoscopy at week 8, and subjects originally randomized into the investigational cohort at week 0 will receive placebo FMP250 by flexible sigmoidoscopy at week 8. Lastly, all subjects will be contacted for follow-up phone calls every subsequent 6 months for the next year.
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Being tested
- Fecal Microbiota Transplantation, Psyllium Husk Powder
- Keywords
- FMT, Fecal Microbiota Transplantation, Inflammatory Bowel Diseases
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationDrug
Also called FMP250, FMT
The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8.
Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery.
Psyllium Husk PowderDietary supplement
All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy.
Psyllium husk powder is the dried and powdered form of a psyllium seed coat.
| Study group | Role | What they receive |
|---|---|---|
| Investigational FMT | Experimental | Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy.
Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Receives: Drug: Fecal Microbiota Transplantation |
| Investigational FMT + psyllium fiber | Active comparator | Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. They will also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks.
Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Receives: Drug: Fecal Microbiota Transplantation; Dietary Supplement: Psyllium Husk Powder |
| Placebo FMT +/- psyllium fiber | Placebo comparator | Participants will be blindly randomized to receive a single dose of placebo FMT during the week 0 colonoscopy. They may or may not also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks.
Additionally, participants will blindly receive a single dose of investigational FMT during the week 8 by flexible sigmoidoscopy. Receives: Dietary Supplement: Psyllium Husk Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response
Clinical response at week 8 post-FMT, as defined by the reduction of the Mayo scoring system by >3 points (+30% reduction) with an accompanying decrease in the sub-score for rectal bleeding of at least 1 point
Measured: Week 8 post-FMT
Secondary outcomes (3)
Clinical Remission
Clinical remission at week 8 post-FMT, as defined by Mayo score ≤ 2 without any subscore >1
Measured: Week 8 post-FMT
Endoscopic Response or Remission
Endoscopic response or remission at week 8 post-FMT, as defined by a Mayo endoscopic sub-score 0-1 with at least a 1-point reduction from baseline or a Mayo endoscopic sub-score of 0
Measured: Week 8 post-FMT
Number of Treatment or Disease Related Adverse Events.
Adverse event counts are cumulative frequencies of adverse and severe adverse events assessed at Week 0 Colonoscopy - Week 12 post-FMT, 6 months post-FMT, and 1 year post-FMT.
Measured: Week 0 Colonoscopy - Week 12 post-FMT, 6 months post-FMT, and 1 year post-FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start31 Jan 2020
- Primary completion9 Jun 2023
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Eligible subjects will be randomly assigned to one of the three (Placebo or Investigational FMT +/- Psyllium) treatment groups. A series of randomized blocks of 6-10 will be generated with a 1:1:1 allocation ratio.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation, National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Randy Longman, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998488
- Sponsor's protocol ID
- 19-04020045
- Other IDs
- 5R01DK128257
- Acronym
- MINDFUL
- Status last verified
- Dec 2024
- First submitted
- 24 Jun 2019
- Last updated
- 3 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacob V, Crawford C, Cohen-Mekelburg S, Viladomiu M, Putzel GG, Schneider Y, Chabouni F, O'Neil S, Bosworth B, Woo V, Ajami NJ, Petrosino JF, Gerardin Y, Kassam Z, Smith M, Iliev ID, Sonnenberg GF, Artis D, Scherl E, Longman RS. Single Delivery of High-Diversity Fecal Microbiota Preparation by Colonoscopy Is Safe and Effective in Increasing Microbial Diversity in Active Ulcerative Colitis. Inflamm Bowel Dis. 2017 Jun;23(6):903-911. doi: 10.1097/MIB.0000000000001132.
PubMed 28445246Gogokhia L, Tran N, Grier A, Nagayama M, Xiang G, Funez-dePagnier G, Lavergne A, Ericsson C, Ben Maamar S, Zhang M, Battat R, Scherl E, Lukin DJ, Longman RS. Donor composition and fiber promote strain engraftment in a randomized controlled trial of fecal microbiota transplant for ulcerative colitis. Med. 2025 Sep 12;6(9):100707. doi: 10.1016/j.medj.2025.100707. Epub 2025 Jun 2.
PubMed 40460824
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled Clinical Trial Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Subsequent Dietary Fiber in Patients With Moderate Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03998488
- Acronym / sponsor ID
- MINDFUL / 19-04020045
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Keywords
- FMT, Fecal Microbiota Transplantation, Inflammatory Bowel Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Foundation, National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Posted 2 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double-blind, randomized, placebo-controlled clinical trial examining the efficacy and safety of Fecal Microbiota Transplantation (FMT) and high fiber supplementation in patients with active mild to moderate Ulcerative Colitis (UC). All enrolled subjects will provide serological, stool and mucosal specimen at each clinic visit to help further define the alterations in microbial profiles and immune cell function in response to psyllium fiber after FMT treatment.
Detailed description
This is a randomized, double-blind, placebo-controlled clinical trial with the following treatment assignments:
- Investigational FMT (one-time)
- Subject will blindly receive investigational FMT once at day 0 colonoscopy
- Subjects in this group will blindly receive placebo FMP250 at week 8 by flexible sigmoidoscopy.
- Investigational FMT (one-time) + Psyllium (2x/day for 8 weeks)
- Subject will blindly receive investigational FMT once at day 0 colonoscopy
- Subjects in this group will blindly receive placebo FMP250 at week 8 by flexible sigmoidoscopy.
- Placebo FMT (one-time) +/- Psyllium (2x/day for 8 weeks)
- Subject will blindly receive placebo FMT once at day 0 colonoscopy
- Subjects in this group will blindly receive investigational FMP250 at week 8 by flexible sigmoidoscopy.
Subjects will blindly receive the investigational or placebo FMP250 treatment if they meet all inclusion and exclusion criteria during the day 0 screening colonoscopy. Subjects will receive follow-up phone calls at day 1, week 2, week 6, and week 10 post-FMT and will return for clinic visits at week 4, week 8 and week 12 post-FMT. Stool and blood samples will be collected for research purposes from subjects at every clinic visit (Day 0 colonoscopy, Week 4, Week 8, and Week 12). Mucosal biopsies will also be taken during the initial colonoscopy, at day 0 and during the follow-up flexible sigmoidoscopy at week 8. At week 8 post-FMT, all subjects will be evaluated by flexible sigmoidoscopy. Subjects originally randomized into the placebo cohort at week 0 will receive investigational FMP250 by flexible sigmoidoscopy at week 8, and subjects originally randomized into the investigational cohort at week 0 will receive placebo FMP250 by flexible sigmoidoscopy at week 8. Lastly, all subjects will be contacted for follow-up phone calls every subsequent 6 months for the next year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Eligible subjects will be randomly assigned to one of the three (Placebo or Investigational FMT +/- Psyllium) treatment groups. A series of randomized blocks of 6-10 will be generated with a 1:1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Investigational FMT | Experimental | Drug: Fecal Microbiota TransplantationParticipants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. |
| Investigational FMT + psyllium fiber | Active comparator | Drug: Fecal Microbiota Transplantation, Dietary Supplement: Psyllium Husk PowderParticipants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. They will also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. |
| Placebo FMT +/- psyllium fiber | Placebo comparator | Dietary Supplement: Psyllium Husk PowderParticipants will be blindly randomized to receive a single dose of placebo FMT during the week 0 colonoscopy. They may or may not also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of investigational FMT during the week 8 by flexible sigmoidoscopy. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or Female ≥ 18 years of age.
- Documentation of prior history of mild to moderate UC.
- Endoscopy confirmed active UC ≥ 15 centimeters at week 0 screening colonoscopy.
- Patients must have a descending intact colon.
- Patients taking steroid or biologic therapy must be on a stable dose for 4 weeks prior to screening and maintained throughout the trial.
Key exclusion criteria (13 listed)
- Biopsy proven Crohn's disease
- UC patients with severe disease (defined as a total mayo score >10)
- Clinical complications requiring emergent management (e.g. stricture, bowel obstruction, perforation and/or abscess)
- Concurrent C. difficile or other infections
- Primary sclerosing cholangitis
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 |
|---|---|---|
| Fecal Microbiota TransplantationAlso: FMP250, FMTThe proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery. | Drug | Investigational FMT, Investigational FMT + psyllium fiber |
| Psyllium Husk PowderAll subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat. | Dietary supplement | Investigational FMT + psyllium fiber, Placebo FMT +/- psyllium fiber |
Primary outcome
Clinical Response
Time frame: Week 8 post-FMT
Clinical response at week 8 post-FMT, as defined by the reduction of the Mayo scoring system by >3 points (+30% reduction) with an accompanying decrease in the sub-score for rectal bleeding of at least 1 point
3 secondary outcomes
Clinical Remission
Time frame: Week 8 post-FMT
Endoscopic Response or Remission
Time frame: Week 8 post-FMT
Number of Treatment or Disease Related Adverse Events.
Time frame: Week 0 Colonoscopy - Week 12 post-FMT, 6 months post-FMT, and 1 year post-FMT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28445246Jacob V, Crawford C, Cohen-Mekelburg S, Viladomiu M, Putzel GG, Schneider Y, Chabouni F, O'Neil S, Bosworth B, Woo V, Ajami NJ, Petrosino JF, Gerardin Y, Kassam Z, Smith M, Iliev ID, Sonnenberg GF, Artis D, Scherl E, Longman RS. Single Delivery of High-Diversity Fecal Microbiota Preparation by Colonoscopy Is Safe and Effective in Increasing Microbial Diversity in Active Ulcerative Colitis. Inflamm Bowel Dis. 2017 Jun;23(6):903-911. doi: 10.1097/MIB.0000000000001132.
- Derived from this study: PubMed 40460824Gogokhia L, Tran N, Grier A, Nagayama M, Xiang G, Funez-dePagnier G, Lavergne A, Ericsson C, Ben Maamar S, Zhang M, Battat R, Scherl E, Lukin DJ, Longman RS. Donor composition and fiber promote strain engraftment in a randomized controlled trial of fecal microbiota transplant for ulcerative colitis. Med. 2025 Sep 12;6(9):100707. doi: 10.1016/j.medj.2025.100707. Epub 2025 Jun 2.
- 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. This study is not recruiting at the moment.
Randy Longman, MD, PhD principal investigator
Weill Medical College of Cornell University
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 Fecal Microbiota Transplantation and Psyllium Husk Powder in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Weill Medical College of Cornell University 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 11 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: finished, as of the sponsor's last update on 3 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 2 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Response (time frame: Week 8 post-FMT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03998488, which also lists 2 linked publications.
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 3 Jan 2025.