What is PRIM-DJ2727 studying for constipation and bloating in systemic sclerosis?

PRIM-DJ2727 is being studied to evaluate its safety and effects on gut microbiome diversity and symptoms in adults with systemic sclerosis-related constipation or bloating. The research aims to understand if microbiome transplantation can improve digestive symptoms and microbiome health. The trial is sponsored by The University of Texas Health Science Center, Houston.

Who may be eligible for this constipation and bloating clinical trial?

Adults aged 18 or older with systemic sclerosis diagnosed by specific criteria and experiencing constipation or bloating meeting Rome IV criteria may be eligible. Participants must be able to follow study procedures and not currently taking probiotics or certain antibiotics. Please review eligibility criteria for more details.

Is there any cost to participate in this constipation and bloating clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06827977

Microbiome Transplantation Study to Treat Constipation and Bloating in Adults with Systemic Sclerosis

Led by The University of Texas Health Science Center, Houston · Updated on 2026-07-08

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying adults with systemic sclerosis who experience constipation andor significant bloating. The study aims to characterize the gut microbiome in these patients and evaluate the safety and potential improvements in microbiome diversity and symptoms after receiving microbiome transplantation. This phase 2 trial focuses on understanding how frozen or lyophilized microbiome transplant products affect these digestive issues in systemic sclerosis. Participants will be randomly assigned to receive either the PRIM-DJ2727 microbiome transplant or a placebo. Treatment includes taking capsules twice weekly from week 2 through week 10 and receiving a retention enema at baseline and week 11. The study uses a quadruple masking design to compare the effects of the microbiome transplant versus placebo on digestive symptoms and microbiome changes. During the study, participants will complete questionnaires assessing constipation and bloating symptoms before treatment and at weeks 11 to 12. Researchers will also monitor gut transit times with Sitz markers and X-rays, analyze microbiome diversity and metabolome changes, and track inflammatory markers and short-chain fatty acids in stool samples. Safety and tolerability are closely observed throughout the 12-week study period, which includes follow-up assessments after treatment.

CONDITIONS

Brief Title

A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Seen in the UT Houston Scleroderma Center
Meet 2013 ACR/EULAR or CREST criteria for systemic sclerosis
Meet Rome IV criteria for constipation and/or significant bloating
Willing to sign informed consent
Likely to survive at least 1 year after enrollment
Able to follow study procedures and attend follow-up
Sexually active males and females of childbearing potential must agree to use effective birth control during treatment and follow-up
Female participants of childbearing potential must have a negative pregnancy test within 72 hours before the procedure
Agree to maintain a stable diet for at least 4 weeks before and throughout the study
Have an attending physician for non-transplant care

You will not qualify if you...

Constipation or bloating caused by conditions other than systemic sclerosis (e.g., inflammatory bowel disease, medication effects, significant diabetes, hypothyroidism)
Unwilling to stop probiotic supplements during the study
History of total or hemicolectomy or presence of a colostomy
Unable to tolerate microbiome transplant via enema or swallow capsules
Require systemic antibiotic therapy within 4 weeks before the study
On immunosuppression with unstable dose within 4 weeks before enrollment

Research Team

Zsuzsanna McMahan, MD, MHS

Ashish P Balar, MBBS, MPH

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