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Fecal Microbiota Transplantation
Probiotics for Ulcerative Colitis
Phase 2
Recruiting
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult ≥18 years of age
Remission of UC based on clinical grounds (partial Mayo score of ≤2 with each subscore ≤1), and on stable maintenance therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
Study Summary
This trial will study whether a certain type of probiotic can help people with ulcerative colitis who are in remission.
Who is the study for?
Adults over 18 with Ulcerative Colitis in remission can join this trial. They must have had active UC within the last year, be on stable therapy, and agree to use birth control if applicable. Exclusions include other GI conditions, certain infections like HIV or Hepatitis B/C, compromised immune systems, recent FMT or investigational drugs, inability to take oral capsules, pregnancy/breastfeeding intentions during the study.Check my eligibility
What is being tested?
The trial tests lyophilized PRIM-DJ2727 capsules against placebos for preventing Ulcerative Colitis relapse. It involves taking these orally and monitoring gut microbiota changes over time to see how they relate to clinical outcomes compared with a placebo.See study design
What are the potential side effects?
While specific side effects are not listed here, fecal microbiota transplantation could potentially cause digestive discomforts such as bloating or gas; there's also a risk of infection transmission despite screening donor material.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My ulcerative colitis is in remission and I'm on a stable treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patients in remission after administering 12 weeks of PRIM-DJ2727 capsules will be measured by partial Mayo score ≤ 3
Secondary outcome measures
Quality of life will be characterized by health-related quality of life score.
Subject-reported score in Hospital Anxiety and Depression Scale
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Patients with UC will receive FMT capsulesExperimental Treatment1 Intervention
Patients with ulcerative colitis will receive fecal microbiota capsules from 3 healthy donors
Group II: Patients with UC will receive placeboPlacebo Group1 Intervention
Patients with ulcerative colitis will receive matching placebo capsules. Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PRIM-DJ2727
2019
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,902 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any antibiotics in the last 14 days.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I cannot take pills in capsule form.I have had active ulcerative colitis in the last year.I have had recurring C. difficile infections or a fecal transplant in the last 6 months.I agree to use effective birth control during the study.I am 18 years old or older.I have a history of bile acid diarrhea.I have a history of active gastrointestinal conditions.My immune system is weak due to a condition or medication like high-dose prednisone.I have a history of cancer but it's either superficial or I'm on maintenance therapy.My ulcerative colitis is in remission and I'm on a stable treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with UC will receive FMT capsules
- Group 2: Patients with UC will receive placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate figure of participants in this experiment?
"Affirmative. Information on clinicaltrials.gov reveals that this medical study is currently enrolling volunteers, with the original posting taking place in September 2020 and the last update being made in May 2022. The trial requires 58 participants to be recruited at a single centre."
Answered by AI
Has the FDA approved PRIM-DJ2727 for public consumption?
"The safety of PRIM-DJ2727 was rated 2 out of 3 as this is a Phase 2 trial, indicating an absence of efficacy data but some supporting its security."
Answered by AI
Are any participants being recruited for this clinical experiment presently?
"Affirmative. The clinicaltrials.gov website supports that this medical trial is actively looking for participants, which was initially posted on September 14th 2020 and recently updated on May 9th 2022. 58 individuals from 1 sites are being sought to take part in the experiment."
Answered by AI
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