Tests a microbiome transplant for constipation and bloating in systemic sclerosis
Tests a gut bacteria treatment for constipation and bloating in adults with systemic sclerosis.
Plain-language title generated from the registry record
Registry title: A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis
Key facts
- Where
- Houston, United StatesSee the site
- Phase
- Phase 2
Where in United States
- The University of Texas Health Science Center at HoustonHouston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The University of Texas Health Science Center, Houston
- Trial code
- NCT06827977
- Record updated
- 8 July 2026
- Original description
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.Read full original descriptionShow less
A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis
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.
Inclusion: 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.
Exclusion: 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; 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.