NCT04373473View on ClinicalTrials.gov

Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis

PHASE2RecruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

September 14, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Adults With Ulcerative Colitis
Interventions
DRUG

PRIM-DJ2727

Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727 capsules consists of lyophilized microbiota suspension from well-screened donors. Microbiota from three donors will be combined to make the product.

DRUG

Placebos

Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria.

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