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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
Must not have
Females who are pregnant, breastfeeding, or planning to become pregnant during the study
Unable to take multiple capsules orally
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Summary
This trial is testing freeze-dried PRIM-DJ2727 capsules taken by mouth in people with ulcerative colitis who are not currently experiencing symptoms. The treatment might work by changing gut bacteria to help keep the disease from coming back.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
Select...
I cannot take pills in capsule form.
Select...
I have a history of bile acid diarrhea.
Select...
My immune system is weak due to a condition or medication like high-dose prednisone.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Fecal Microbiota Transplantation (FMT) involves transferring stool from a healthy donor to a UC patient's gastrointestinal tract to restore a balanced gut microbiota, thereby reducing inflammation and improving gut health. This is achieved by increasing microbial diversity and promoting the growth of beneficial bacteria.
Other common treatments for UC, such as aminosalicylates, corticosteroids, immunomodulators, and biologics, work by reducing inflammation and modulating the immune response. Understanding these mechanisms is crucial for UC patients to select the most appropriate treatment based on disease severity and individual response.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
949 Previous Clinical Trials
344,967 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.
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