drugset
drugset / Trial / NCT06827977

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

NCT06827977 ↗

Phase 2 Recruiting 21 enrolled The University of Texas Health Science Center, Houston
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-03-03
Primary completion
2027-06-30
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject PRIM-DJ2727 Other / unclassified 50 g Oral
Subject PRIM-DJ2727 Other / unclassified 60 g Oral

Indications

constipation disorder gas bloat syndrome