21
Participants
Start Date
March 3, 2025
Primary Completion Date
May 30, 2026
Study Completion Date
September 26, 2026
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."
Placebo
Placebo will be administered as capsules from week 2-10 and as enema at baseline and week 11.
RECRUITING
The University of Texas Health Science Center at Houston, Houston
The University of Texas Health Science Center, Houston
OTHER