CP-101 for Ulcerative Colitis

Recruiting in Boston (>99 mi)

Overseen By Jessica Allegretti

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Brigham and Women's Hospital

Must not be taking: Antibiotics

Disqualifiers: Severe UC, Crohn's, Antibiotic use, others

Compensation: Varies

Number of Visits: 19

Duration: 8 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests CP101, a pill that adds good bacteria to the gut, on people with mild-to-moderate Ulcerative Colitis. The goal is to see if these good bacteria can help reduce inflammation and improve symptoms.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications, but it mentions that participants should have stable dosing of their current medications. It is best to discuss your specific medications with the trial team.

Eligibility Criteria

Adults over 18 with mild-to-moderate Ulcerative Colitis extending at least 15 cm from the anal verge can join. They must have stable medication use and a recent colonoscopy confirming their condition. Excluded are those with severe UC, recent antibiotic or investigational drug use, certain infections, prior FMT treatment, significant medical conditions that could affect results, or inability to ingest capsules.

Inclusion Criteria

My ulcerative colitis is mild to moderate, with a Mayo score between 4 and 9.

I have been diagnosed with ulcerative colitis.

My condition is located more than 15 cm from the anal opening.

Exclusion Criteria

I have a history of Crohn's disease or indeterminate colitis.

I expect to take antibiotics soon for a planned procedure.

I have or might have a severely enlarged colon or a blockage in my small intestine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive CP101 or placebo with an initial induction dose of 10 capsules daily for 5 days, followed by either extended induction with CP101 or placebo through Week 8

8 weeks

Multiple visits for assessments at Day 6, Week 4, and Week 8

Follow-up

Participants are monitored for long-term safety, engraftment, and clinical outcomes through Week 24

16 weeks

Visits at Week 12, Week 16, and Week 24

Treatment Details

Interventions

• CP-101

Trial Overview The trial is testing CP101, an oral microbiome therapeutic for Ulcerative Colitis. Participants will be randomly assigned to receive either a short or extended induction dosing of CP101. The study will monitor changes in the microbiome over several weeks up to Week 24.

Participant Groups

Group I: CP101 Experimental Treatment 1 Intervention

Extended Induction: Participants will receive the short induction dose of CP101 comprising 10 capsules daily for 5 days. Participants in this arm will then receive an extended induction daily dose of five CP101 capsules through Week 8.

Group II: CP101 + Placebo Placebo Group 1 Intervention

Short Induction: Participants will receive the short induction dose of CP101 comprising 10 capsules daily for 5 days. Participants in this arm will then receive 5 capsules of placebo through Week 8.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+