Microbiome transplant to treat constipation and bloating in systemic sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study compares frozen and lyophilized formulations of the microbiome transplant product PRIM‑DJ2727 against placebo to measure tolerability and safety in patients with systemic sclerosis–related constipation and/or significant bloating. Researchers will profile the colonic microbiome (α- and β-diversity) and metabolome before and after treatment and track changes in fecal short-chain fatty acids. Clinical outcomes include patient-reported constipation and bloating, colonic transit measurements, and a global impression of change, while systemic and fecal inflammatory markers will be monitored for biologic correlates. The study is conducted at the UTHealth Scleroderma Center with adults who meet SSc and Rome IV criteria and who can adhere to a stable diet and follow-up schedule.

Why it matters

Who can join: the full rules

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

Where it's running

• The University of Texas Health Science Center at Houston
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Zsuzsanna McMahan, MD, MHS — The University of Texas Health Science Center, Houston
• Study coordinator: Zsuzsanna McMahan, MD, MHS
• Email: Zsuzsanna.H.McMahan@uth.tmc.edu
• Phone: 713-500-7531

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.