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Microbiome Therapy

FMT + Dietary Fiber for Ulcerative Colitis (MINDFUL Trial)

Phase 2

Waitlist Available

Led By Randy Longman, MD, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or Female ≥ 18 years of age.

Patients must have a descending intact colon.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 colonoscopy - week 12 post-fmt

Awards & highlights

MINDFUL Trial Summary

This trial is testing whether FMT or high fiber supplementation can help patients with UC. All enrolled subjects will provide stool and mucosal samples at each visit to help define how these treatments alter the microbiome and immune cell function.

Who is the study for?

Adults with mild to moderate Ulcerative Colitis confirmed by endoscopy can join this trial. They must have a stable dose of steroids or biologics for 4 weeks before and during the study, undergo baseline health tests, and stop certain antibiotics 48 hours before treatment. People with severe UC, Crohn's disease, recent cancer treatments, tuberculosis, significant lab abnormalities or allergies to psyllium husk cannot participate.Check my eligibility

What is being tested?

The trial is testing if Fecal Microbiota Transplantation (FMT) combined with high fiber from Psyllium Husk Powder helps patients with Ulcerative Colitis. Participants are randomly assigned to receive either the real treatments or placebos without knowing which one they're getting.See study design

What are the potential side effects?

Potential side effects may include digestive discomfort such as bloating and gas due to high fiber intake and risks associated with FMT like infection transmission or adverse immune reactions.

MINDFUL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My lower large intestine is healthy and not surgically altered.

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My ulcerative colitis affects more than 15cm of my colon.

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I am willing to undergo urine, blood, and stool tests before treatment.

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I will stop taking specific antibiotics 2 days before my treatment.

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I have been on a stable dose of steroids or biologic therapy for at least 4 weeks.

Select...

My lower large intestine is healthy and not surgically altered.

Select...

My ulcerative colitis affects more than 15cm of my colon.

Select...

I have a history of mild to moderate ulcerative colitis.

MINDFUL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 colonoscopy - week 12 post-fmt

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0 colonoscopy - week 12 post-fmt

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 colonoscopy - week 12 post-fmt for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical Response

Secondary outcome measures

Change in Number of disease-related complications such as hospitalizations, surgeries and endoscopies, medical complications, and mortality

Clinical Remission

Endoscopic Response or Remission

+1 more

Side effects data

From 2020 Phase 1 & 2 trial • 50 Patients • NCT03106844

44%

Diarrhea

26%

Abdominal Pain

16%

Rectal Bleeding

12%

Constiption

10%

Fever

10%

Nausea

Vomiting

Fatigue

Heart Burn

Chills

Migraine

Yeast Infection

Anemia

IBD Flare

100%

80%

60%

40%

20%

Study treatment Arm

Treatment

MINDFUL Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Investigational FMTExperimental Treatment1 Intervention

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.

Group II: Investigational FMT + psyllium fiberActive Control2 Interventions

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.

Group III: Placebo FMT +/- psyllium fiberPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fecal Microbiota Transplantation

2016

Completed Phase 2

~350

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Crohn's and Colitis FoundationOTHER

43 Previous Clinical Trials

28,098 Total Patients Enrolled

16 Trials studying Ulcerative Colitis

12,928 Patients Enrolled for Ulcerative Colitis

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,330,537 Total Patients Enrolled

3 Trials studying Ulcerative Colitis

320 Patients Enrolled for Ulcerative Colitis

Randy Longman, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University

1 Previous Clinical Trials

120 Total Patients Enrolled

Media Library

Fecal Microbiota Transplantation (Microbiome Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03998488 — Phase 2

Ulcerative Colitis Research Study Groups: Investigational FMT, Investigational FMT + psyllium fiber, Placebo FMT +/- psyllium fiber

Ulcerative Colitis Clinical Trial 2023: Fecal Microbiota Transplantation Highlights & Side Effects. Trial Name: NCT03998488 — Phase 2

Fecal Microbiota Transplantation (Microbiome Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03998488 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Fecal Microbiota Transplantation as a viable treatment option?

"The safety of Fecal Microbiota Transplantation is estimated to be a 2 on our internal scale due to the relative lack of data supporting its efficacy in comparison to existing evidence for its safety."

Answered by AI

How many participants is this trial accommodating?

"Affirmative, the information hosted on clinicaltrials.gov suggests that this research endeavour is still open for recruitment. It was first advertised on January 31st 2020 and has since been updated on February 14th 2022. The trial calls for 135 participants who will be sourced from 1 particular centre."

Answered by AI

Who is eligible to take part in this clinical trial?

"This study is enlisting 135 individuals between the ages of 18 and 89 who have an inflammatory bowel ailment. To be eligible, male or female participants must document a history of mild-to-moderate ulcerative colitis (UC) evidenced by endoscopic exam results at screening colonoscopy which demonstrate active UC ≥ 15 cm with a total Mayo scoring of 4-10 and subscore ≥ 1 plus they must possess an uncut descending colon. Additionally, those receiving steroid or biologic therapy must maintain their dosage for four weeks prior to screening as well as throughout the trial period whilst discontinuing anti-rCDI antibiotics 48 hours"

Answered by AI

Is the age eligibility for this research restricted to those under 45?

"This research is open to individuals aged 18 and older, but not exceeding 89 years of age."

Answered by AI

Are new participants still being considered for this clinical research?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical experiment is currently seeking out participants following its initial post date of January 31st 2020 and a recent update made February 14th 2022. The trial requires 135 people at one specific location."

Answered by AI

Recent research and studies

Inflammatory Bowel DiseasesJournal

Single Delivery of High-diversity Fecal Microbiota Preparation by Colonoscopy Is Safe and Effective in Increasing Microbial Diversity in Active Ulcerative Colitis

Jacob, Vinita, Carl Crawford, Shirley Cohen-Mekelburg, Monica Viladomiu, Gregory G. Putzel, Yecheskel Schneider, Fatiha Chabouni, et al.. 2017. “Single Delivery of High-diversity Fecal Microbiota Preparation by Colonoscopy Is Safe and Effective in Increasing Microbial Diversity in Active Ulcerative Colitis”. Inflammatory Bowel Diseases. Oxford University Press (OUP). doi:10.1097/mib.0000000000001132.

clinicaltrials.govStudy

Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis

2020. "Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03998488.

All > Inflammatory Bowel Disease > Colitis