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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06827977
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bloating
  • Constipation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PRIM-DJ2727 — DRUG
    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.
  • Placebo — DRUG
    Placebo will be administered as capsules from week 2-10 and as enema at baseline and week 11.

Study Details

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.

Key Dates

Start date
Mar 3, 2025
Status verified
Jun 2025
Primary completion
May 30, 2026
Completion
Sep 26, 2026

Study Design

Enrollment
21 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PRIM-DJ2727
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in symptoms and signs of constipation and/or significant bloating as assessed by total score on the University of California, Los Angeles Gastrointestinal Tract Questionnaire, version 2.0 (UCLA GIT 2.0) [ Time Frame: pre-transplant , post-treatment at week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Zsuzsanna McMahan, MD, MHS
[email protected]
713-500-7531
Ashish P Balar, MBBS, MPH
[email protected]
713-500-4409

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