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

PHASE2RecruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

March 3, 2025

Primary Completion Date

May 30, 2026

Study Completion Date

September 26, 2026

Conditions
ConstipationBloating
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.

Trial Locations (1)

77030

RECRUITING

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
lead

The University of Texas Health Science Center, Houston

OTHER