Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05852574
PHASE1

CP101 for the Treatment of Ulcerative Colitis

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

Summary

This is a dose ranging exploratory phase 1 pilot study to assess engraftment, safety, and efficacy of CP101, an oral microbiome therapeutic, in participants with active mild-to-moderate Ulcerative colitis. A total of 30 patients who meet eligibility criteria will be randomized 1:1 to either a short or extended induction dosing with CP101. An assessment of the microbiome will occur at baseline, Day 6, Week 4, Week 8, Week 12, Week 16, and Week 24.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-09-01

Completion Date

2025-12-01

Last Updated

2025-09-16

Healthy Volunteers

No

Interventions

DRUG

CP-101

CP101 is an investigational oral microbiome drug designed to deliver a complete and functional microbiome to durably repair intestinal dysbiosis, which is being evaluated for the prevention of recurrent CDI. CP101 contains live microbial communities, derived from rigorously screened human donor stool that is tested, stabilized, characterized, and formulated into capsules designed specifically for delivery into the small bowel for release, to avoid potential degradation by gastric acid.

DRUG

CP-101 + Placebo

The placebo in this trial will be presented in capsules that are identical in size, smell, texture, and appearance to those of the CP101 capsules. These will be produced by the BWH investigational drug service

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States