15
Participants
Start Date
May 15, 2019
Primary Completion Date
October 9, 2022
Study Completion Date
October 12, 2022
PRIM-DJ2727
Twice filtered fecal microbiota product from three screened healthy donors will be lyophilized and encapsulated in enteric-coated capsules. Each dose of enteric coated capsules consists of 60 grams of stool and will be administered orally twice-weekly for 12 consecutive weeks
Placebo oral capsule
Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria. The placebo will consist of Lactose (spray-dried United States Pharmacopeia (USP) 64.385gm), food color, powdered Black, Brown, and Yellow in the enteric capsules. Placebo will be administered orally twice-weekly for 12 consecutive weeks
The University of Texas Health Science Center at Houston, Houston
Collaborators (1)
Kelsey Research Foundation
OTHER
The University of Texas Health Science Center, Houston
OTHER