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Microbiome Therapeutic
CP-101 for Ulcerative Colitis
Phase 1
Recruiting
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial will assess an oral microbiome therapy in 30 people with mild-to-moderate Ulcerative Colitis to find if it is safe, effective, and if it works.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
As this is an exploratory Phase 1 trial primarily focused on safety and efficacy, specific side effects of CP101 are not detailed but may include typical drug-related gastrointestinal symptoms and potential allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate engraftment of CP101-associated microbes after extended induction compared to the short induction arm
To evaluate the safety and tolerability of CP101
Secondary outcome measures
To evaluate the effect of CP101 on induction of clinical remission
To evaluate the effect of CP101 on induction of clinical response
To evaluate the effect of CP101 on induction of endoscopic remission
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CP101Experimental Treatment1 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 + PlaceboPlacebo Group1 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.
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,616 Previous Clinical Trials
11,470,918 Total Patients Enrolled
2 Trials studying Ulcerative Colitis
136 Patients Enrolled for Ulcerative Colitis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of Crohn's disease or indeterminate colitis.I expect to take antibiotics soon for a planned procedure.My ulcerative colitis is mild to moderate, with a Mayo score between 4 and 9.I have or might have a severely enlarged colon or a blockage in my small intestine.I have had a fever over 38.3°C.I have a diagnosed immune deficiency condition.I cannot have a colonoscopy due to certain health risks or recent surgeries.My ulcerative colitis is severe, with a Mayo score of 10 or higher.I have been diagnosed with ulcerative colitis.My condition is located more than 15 cm from the anal opening.I have mild to moderate ulcerative colitis confirmed by a recent colonoscopy.My condition is limited to inflammation in the lower part of my rectum.I cannot swallow pills due to severe nausea or other stomach issues.I am not currently undergoing intensive cancer treatment, but may be on maintenance therapy.I currently have an active intestinal blockage.I have not taken antibiotics in the last month.I have had a fecal microbiota transplant in the last 6 months.I have had surgery on my intestines, excluding gallbladder or appendix removal.I have cancer, but it's not skin cancer (basal or squamous cell).I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: CP101
- Group 2: CP101 + Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has CP101 obtained authorization from the FDA?
"With limited clinical data available, CP101 was scored a 1 on the safety index. This is due to it being in Phase 1 of its trial and having only preliminary evidence supporting efficacy and safety."
Answered by AI
Is this clinical investigation presently recruiting participants?
"Data on clinicaltrials.gov indicates that this study is not currently recruiting patients, with the original posting date being June 1st 2023 and the last update occurring on May 9th 2023. However, other trials are actively seeking participants right now - 424 of them to be precise!"
Answered by AI
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