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

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.

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