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Fecal Microbiota Transplantation
Fecal Microbiota Transplant for Ulcerative Colitis
Phase 1
Waitlist Available
Led By Herbert L DuPont, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline,end of treatment (4 weeks after baseline), 6 months follow up
Awards & highlights
Study Summary
This trial tests two ways of delivering FMT for UC, to check safety, effectiveness and impact on gut microbiome.
Who is the study for?
This trial is for adults with active Ulcerative Colitis (UC) who are not pregnant, breastfeeding, or planning pregnancy. They must have a Partial Mayo score ≥ 3 and agree to use birth control. Excluded are those with severe UC, recent antibiotics use, certain infections like HIV/Hepatitis B/C, past FMT or recurrent C. difficile infection within 6 months, compromised immune systems or significant uncontrolled diseases.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of fecal microbiota transplantation (FMT) in treating UC using two methods: frozen FMT via enema and lyophilized powder in capsules. It also examines changes in gut microbiome diversity after treatment.See study design
What are the potential side effects?
Potential side effects may include discomfort from enema administration or taking multiple capsules, digestive disturbances due to changes in gut flora, allergic reactions to donor material, and risk of infection transmission.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline,end of treatment (4 weeks after baseline)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline,end of treatment (4 weeks after baseline)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in proportion of antibody-coated microbiota as assessed by the antibiotic susceptibility test
Disease severity as assessed by the Partial Mayo Score (PMS) for Ulcerative Colitis (UC)
Safety as assessed by the adverse events
Secondary outcome measures
Change in anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS)
Change in fecal microbiota diversity and genera as assessed by sequencing
Change in proportion of antibody-coated microbiota as assessed by the gut microbiota taxonomy by sequencing
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Experimental: PRIM-DJ2727 - FROZENExperimental Treatment1 Intervention
Group II: Experimental: PRIM-DJ2727 - CAPSULESExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,957 Total Patients Enrolled
Herbert L DuPont, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
5 Previous Clinical Trials
156 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of active gastrointestinal conditions.I cannot take medicine as an enema or swallow many pills.I have a history of bile acid diarrhea.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.My ulcerative colitis is severe, with a Mayo score over 7.I have not taken any antibiotics in the last 14 days.I have had repeated C. difficile infections or a fecal transplant in the last 6 months.I have a history of cancer but it's either superficial or I'm on maintenance therapy.I agree to use effective birth control during the study.I am not pregnant, as confirmed by a negative pregnancy test.My ulcerative colitis is active with a Partial Mayo score of 3 or more.I have a weakened immune system due to a condition or medication like prednisone.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: PRIM-DJ2727 - FROZEN
- Group 2: Experimental: PRIM-DJ2727 - CAPSULES
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How does Experimental: PRIM-DJ2727 - FROZEN affect the wellbeing of patients?
"We assign Experimental: PRIM-DJ2727 - FROZEN a score of 1, as Phase 1 trials usually yield limited evidence for safety and efficacy."
Answered by AI
Are there still patient vacancies in this medical experiment?
"Current information on clinicaltrials.gov indicates that enrollment for this trial has been suspended. The study was initially posted on April 15th, 2023 and subsequently edited on March 23rd, 2023. Fortunately, there are 412 other studies actively recruiting participants at the present time."
Answered by AI
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