Microbiome transplant to treat constipation and bloating in systemic sclerosis
A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis
This Phase 2 trial tests whether a frozen or lyophilized microbiome transplant (PRIM‑DJ2727) can help people with systemic sclerosis who have constipation and/or significant bloating.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06827977 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with systemic sclerosis who meet 2013 ACR/EULAR or CREST criteria and Rome IV criteria for constipation and/or significant bloating, are followed at the UTHealth Scleroderma Center, can consent and adhere to a stable diet and follow-up, and are expected to survive at least one year.
Not a fit: Patients who do not meet the inclusion criteria, whose gastrointestinal symptoms are not related to SSc, or who have contraindications to microbiome transplantation may not receive benefit.
Why it matters
Potential benefit: If successful, the intervention could reduce constipation and bloating, restore healthier gut microbial diversity, and improve quality of life for patients with systemic sclerosis.
How similar studies have performed: Fecal microbiota transplantation has proven highly effective for recurrent C. difficile and has shown some promising but mixed results in functional gut disorders like IBS and constipation, while use specifically in systemic sclerosis remains exploratory.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.