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
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the intestinal bacteria in people with systemic sclerosis-related constipation and/or significant bloating may change after receiving microbiome transplantation. This Phase 2 study aims to understand the safety and tolerability of two types of microbiome transplant products (frozen and lyophilized PRIM-DJ2727) and how these treatments affect gut bacteria diversity and patient symptoms. Participants will be randomly assigned to receive either the microbiome transplant or a placebo. The transplant is given both as capsules taken twice weekly from week 2 through week 10, and as a retention enema at the start and during week 11. The placebo group receives matching capsules and enemas on the same schedule. This design helps compare effects between the active treatment and placebo. During the study, participants will have their symptoms assessed using several questionnaires and stool diaries before treatment and at week 12. Researchers will also monitor gut transit times, inflammatory markers, and changes in gut bacteria. The study includes follow-up visits to evaluate safety and outcomes over 12 weeks. The goal is to track improvements in constipation and bloating and understand changes in gut microbiome composition.
CONDITIONS
Brief 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...
- Are seen in the UT Houston Scleroderma Center (UTHSC)
- Meet 2013 American college of rheumatology (ACR)/European league against rheumatism (EULAR) criteria or CREST criteria for systemic sclerosis
- Meet Rome IV criteria for constipation and/or significant bloating
- Willing to sign an informed consent form
- Likely to survive for at least 1 year after enrollment
- Able to follow study procedures and attend follow-up visits
- Sexually active males and females of childbearing potential must agree to use effective birth control during treatment and follow-up
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours before the procedure
- Agree to maintain a stable diet for at least 4 weeks before and throughout 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 via enema or swallow capsules
- Require systemic antibiotic therapy within 4 weeks before the 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Approximately 10 weeks
Participants receive microbiome transplant capsules twice weekly from week 2 through week 10, with enemas administered at baseline and week 11.
1 visit at baseline, twice-weekly capsule intake from week 2 to week 10, and 1 visit at week 11 for enema administration
Duration - Up to week 12 post-treatment
Participants are monitored for changes in symptoms, microbiome characteristics, and safety after treatment ends.
1 visit at week 12
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
A
Ashish P Balar, MBBS, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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