NCT06827977RecruitingPhase 2
A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 9 Feb 2025
- Start date
- 3 Mar 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT06827977
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 21
- From 3 Mar 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.