A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Constipation, Bloating

In brief

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.

Key facts

Study ID

NCT06827977

Run by

The University of Texas Health Science Center, Houston

People needed

21

Starts

2025-03-03

Expected to finish

2028-06-30

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 SSc
• Meet Rome IV criteria for constipation and/or significant bloating
• Subject willing to sign an informed consent form
• Subject deemed likely to survive for ≥ 1 year after enrollment
• Able to follow study procedure and follow-up
• Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the treatment and follow-up period
• Female subjects of childbearing potential must have a negative pregnancy test in the 72 hours before the procedure
• Subjects who agree to adhere to a stable diet for at least 4 weeks before joining the study and throughout the study
• Subjects must have an attending physician who will provide non-transplant care for the subject

You may not qualify if…

• Subjects with constipation and/or significant bloating from causes not attributed to SSc as determined by the treating physician (e.g., inflammatory bowel disease, medication, significant diabetes, or hypothyroidism, etc.)
• Subjects unwilling to stop taking probiotic supplements during the duration of the study
• Subjects that have post-total or hemicolectomy or the presence of a colostomy
• Subjects unable to tolerate microbiome transplant via enema for any reason or swallow capsules
• Subjects requiring systemic antibiotic therapy 4 weeks before the study
• If subjects are on immunosuppression, the immunosuppression dose should be stable for at least 4 weeks before study enrollment

Where it is running

• The University of Texas Health Science Center at Houston — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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