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A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis
RecruitingPhase 2
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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.
What is being tested
- PRIM-DJ2727 (drug)
- Placebo (drug)
Sponsor: The University of Texas Health Science Center, Houston · Participants: 21 · Started: Mar 3, 2025
Contact the study team
- Zsuzsanna McMahan, MD, MHS · Phone: 713-500-7531
- Ashish P Balar, MBBS, MPH · Phone: 713-500-4409
Official record on ClinicalTrials.gov — NCT06827977
Locations in the U.S.
| Texas | The University of Texas Health Science Center at Houston, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.