NCT06827977 A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis
| NCT ID | NCT06827977 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Constipation |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 21 participants in total. It began in 2025-03-03 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 improvements in the diversity of colonic microbiome and patient symptoms following the administration of either frozen or lyophilized PRIM-DJ2727 microbiota.
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
Contact & Investigator
Zsuzsanna McMahan, MD, MHS
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT06827977 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Constipation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06827977 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06827977 currently recruiting?
Yes, NCT06827977 is actively recruiting participants. Contact the research team at Zsuzsanna.H.McMahan@uth.tmc.edu for enrollment information.
Where is the NCT06827977 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06827977 clinical trial?
NCT06827977 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Zsuzsanna McMahan, MD, MHS at The University of Texas Health Science Center, Houston. The trial plans to enroll 21 participants.