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

NCT06827977 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-06-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PRIM-DJ2727

For oral administration, each dose will contain the number of capsules needed to deliver the lyophilized intestinal bacteria powder derived after lyophilization of 60 g of filtered stool in 300 mL 0.85% NaCl and 2% mannitol. Participants will take the capsules (5-6 capsules twice weekly) from week 2 through week 10. Capsules will be taken over a period of up to one hour to maximize tolerance and ensure the capsules are not expelled by vomiting. For administration via retention enema, which will be done at baseline and week 11, 50 g of filtered, frozen stool in 250 mL of 0.85% sodium chloride (NaCl) will be used.

DRUG

Placebo

Placebo will be administered as capsules from week 2-10 and as enema at baseline and week 11.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Zsuzsanna McMahan, MD, MHS · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2026-05-30
Completion
2026-09-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06827977 on ClinicalTrials.gov