Actively Recruiting
A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis
Led by The University of Texas Health Science Center, Houston · Updated on 2025-06-26
21
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to characterize the intestinal flora in subjects with systemic sclerosis-related constipation and/or significant bloating and to determine safety and trends in improvements in the diversity of colonic microbiome and patient symptoms following the administration of either frozen or lyophilized PRIM-DJ2727 microbiota.
CONDITIONS
Official Title
A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Seen in the UT Houston Scleroderma Center
- Meet 2013 ACR/EULAR or CREST criteria for systemic sclerosis
- Meet Rome IV criteria for constipation and/or significant bloating
- Willing to sign informed consent
- Likely to survive at least 1 year after enrollment
- Able to follow study procedures and attend follow-up
- Sexually active males and females of childbearing potential agree to use effective birth control during treatment and follow-up
- Female participants of childbearing potential have a negative pregnancy test within 72 hours before procedure
- Agree to maintain a stable diet for at least 4 weeks before and during the study
- Have an attending physician for non-transplant care
You will not qualify if you...
- Constipation or bloating caused by conditions other than systemic sclerosis (e.g., inflammatory bowel disease, medication effects, significant diabetes, hypothyroidism)
- Unwilling to stop probiotic supplements during the study
- History of total or hemicolectomy or presence of a colostomy
- Unable to tolerate microbiome transplant by enema or unable to swallow capsules
- Require systemic antibiotics within 4 weeks before study
- On immunosuppression with unstable dose within 4 weeks before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
Z
Zsuzsanna McMahan, MD, MHS
CONTACT
A
Ashish P Balar, MBBS, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here