Could a Stool-Based pill tame ulcerative colitis?
NCT ID NCT05852574
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase study tests CP101, an oral capsule made from healthy donor stool, in 30 adults with mild-to-moderate ulcerative colitis. The goal is to see if the drug can safely restore a healthy gut microbiome and improve symptoms. Participants receive either a short or extended course of CP101 and are monitored for 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CP101 (an oral microbiome drug made from donor stool)
- What this could lead to
- If it works, this could point toward a new way to treat ulcerative colitis by restoring healthy gut bacteria.
- What could go wrong
- This is a very early (Phase 1) and small (30 people) study, so it may not show clear benefit or could have side effects. Success is far from guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
-
Dec 2025
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed informed consent 2. Male or female ≥18 years of age 3. Ulcerative colitis diagnosed by routine clinical, radiographic, endoscopic criteria 4. Active mild-moderate UC as determined by colonoscopy approximately 10-21 days prior to randomization into the study. (flexible sigmoidoscopy permitted if subject has had a full colonoscopy within 12 months of baseline) 5. Mild-moderate UC, defined by a complete Mayo score to include: the sum of rectal bleeding, stool frequency, endoscopic findings and physician global assessment sub-scores totaling ≥4 and ≤9, with each individual sub-group score ≥1.) 6. Disease at least 15 cm from anal verge 7. Stable dosing of concomitant medication Exclusion Criteria: 1. Severe or refractory UC defined as Mayo score ≥10 2. Disease limited to distal proctitis 3. Fever \> 38.3°C 4. Known history of Crohn's disease or indeterminate colitis 5. Inability to ingest capsules (e.g., severe nausea, vomiting, gastroparesis, gastric outlet obstruction, dysphagia and/or history of chronic aspiration). 6. Known or suspected toxic megacolon and/or known small bowel ileus 7. Patients with active intestinal obstruction 8. Antibiotic use within the prior 1 month before randomization 9. Expected to receive antibiotics within 8 weeks of signing the Informed Consent Form (ICF) (i.e., for planned/anticipated procedure) 10. Known stool studies positive for ova and/or parasites or stool culture within the 30 days before enrollment 11. Clostridioides difficile positive stool testing via GDH/EIA toxin testing at Screening Visit 12. Received an investigational drug or vaccine within 3 months before study entry 13. Received an FMT within the last 6 months 14. Patients with anatomic or medical contraindications to colonoscopy, including but not necessarily limited to toxic megacolon, gastrointestinal (GI) fistulas, immediate postoperative status from abdominal surgery, severe coagulopathy, large or symptomatic abdominal aortic aneurysm, or any patient where study physician deems patient at significant risk of complications of colonoscopy 15. Patients with previous colectomy, ostomy, J-pouch, or previous intestinal surgery (excluding cholecystectomy, appendectomy) 16. Unable to complete appropriate washout periods/stop prior therapies, as defined in Section 5.3 17. Patients with known diagnosis primary or secondary immune deficiency e.g., IgA deficiency, SCID, CGD 18. Known active malignancy except for basal cell skin cancer, squamous cell skin cancer 19. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor) 20. Patients with any other significant medical condition that could confound or interfere with the evaluation of safety, tolerability or prevent compliance with the study protocol at the discretion of the investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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