Status:
RECRUITING
A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Constipation
Bloating
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 improvement...
Detailed Description
The purpose of this study is to evaluate the tolerability and safety of frozen and lyophilized microbiome transplant product (PRIM- DJ2727), to characterize the microbiome (α-diversity and β-diversity...
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Key Trial Info
Start Date :
March 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 26 2026
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06827977
Start Date
March 3 2025
End Date
September 26 2026
Last Update
June 26 2025
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030