Ulcerative ColitisPhase 1NCT05852574
CP101 for the Treatment of Ulcerative Colitis
A Phase 1 study testing CP-101 in people with Ulcerative Colitis, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- CP-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 1 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Male or female ≥18 years of age
- Ulcerative colitis diagnosed by routine clinical, radiographic, endoscopic criteria
- 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)
- 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.)
- Disease at least 15 cm from anal verge
- Stable dosing of concomitant medication
Who cannot join
- Severe or refractory UC defined as Mayo score ≥10
- Disease limited to distal proctitis
- Fever > 38.3°C
- Known history of Crohn's disease or indeterminate colitis
- Inability to ingest capsules (e.g., severe nausea, vomiting, gastroparesis, gastric outlet obstruction, dysphagia and/or history of chronic aspiration).
- Known or suspected toxic megacolon and/or known small bowel ileus
Show all 20Show fewer
- Patients with active intestinal obstruction
- Antibiotic use within the prior 1 month before randomization
- Expected to receive antibiotics within 8 weeks of signing the Informed Consent Form (ICF) (i.e., for planned/anticipated procedure)
- Known stool studies positive for ova and/or parasites or stool culture within the 30 days before enrollment
- Clostridioides difficile positive stool testing via GDH/EIA toxin testing at Screening Visit
- Received an investigational drug or vaccine within 3 months before study entry
- Received an FMT within the last 6 months
- 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
- Patients with previous colectomy, ostomy, J-pouch, or previous intestinal surgery (excluding cholecystectomy, appendectomy)
- Unable to complete appropriate washout periods/stop prior therapies, as defined in Section 5.3
- Patients with known diagnosis primary or secondary immune deficiency e.g., IgA deficiency, SCID, CGD
- Known active malignancy except for basal cell skin cancer, squamous cell skin cancer
- Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the detailed description
This dose ranging exploratory phase 1 pilot study will assess engraftment, safety, and efficacy of CP101, an oral microbiome therapeutic, in participants with active mild-to-moderate UC.
Participants with mild-moderate disease, defined as a complete Mayo score of ≥4 to ≤9 will be eligible for enrollment. Eligible participants must have an endoscopic and
histologically confirmed diagnosis of mild-to-moderate UC. Participants must have active disease at endoscopy (Mayo endoscopic score<=1) performed during screening.
Participants who meet eligibility criteria will be randomized 1:1 to either initial induction only or initial and extended induction dosing with CP101. Both arms will receive an initial induction dose of CP101 comprising 10 capsules daily for 5 days. Participants will then either receive extended induction with a daily dosing of five CP101 capsules through Week 8 or matching placebo. Both participants and PI will be blinded to treatment arm allocation.
Participants will be assessed through Week 8 for the primary outcome, engraftment. Safety outcomes (all AEs and safety laboratory values) will be assessed through the 8 week treatment period. In addition, secondary efficacy outcomes of disease remission and response will be evaluated at Week 8. Participants will also be followed through Week 24 for long-term safety, engraftment, and clinical outcomes (including but not limited to remission and response). AEs will be recorded from informed consent through Week 24 trial visit. Blood samples for safety laboratory analysis, as well as blood and stool samples for biomarker assessments will be collected at scheduled trial visits per the Schedule of Assessments.
The primary outcome, engraftment of CP101 associated microbes will be measured utilizing two baseline samples (prior to CP101 administration) and the participant's Week 8 stool sample following Randomization. Additional stool sample collections for microbiome assessment will occur at Day 6, Week 4, 8, 12, 16, and 24.
Participants that experience on-study worsening of their UC or a severe flare requiring the administration of rescue therapy, will be withdrawn from the study but not replaced. They will be considered treatment failures and last values collected will be carried forward.
This study will prospectively enroll approximately 30 adult participants at a single center.
- Conditions
- Ulcerative Colitis
- Being tested
- CP-101, CP-101 + Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-101Drug
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.
CP-101 + PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| CP101 | Experimental | 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. Receives: Drug: CP-101 |
| CP101 + Placebo | Placebo comparator | 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. Receives: Drug: CP-101 + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate engraftment of CP101-associated microbes after extended induction compared to the short induction arm
Quantification of CP101-associated taxa following administration of CP101 that were absent at baseline (pre-CP101 administration)
Measured: 8 weeks
To evaluate the safety and tolerability of CP101
Subject incidence of treatment-emergent adverse events (including treatment-emergent adverse events for clinically significant changes in laboratory parameters and vital signs)
Measured: 8 weeks
Secondary outcomes (3)
To evaluate the effect of CP101 on induction of clinical remission
Partial Mayo score 0 to 2 including rectal bleeding sub-score of 0, a stool frequency score or 0 or 1
Measured: 8 weeks
To evaluate the effect of CP101 on induction of clinical response
A decrease from baseline in the partial Mayo score of ≥2 points and at least 30% reduction from baseline, and a decrease in the rectal bleeding sub-score of ≥1 or an absolute rectal bleeding sub-score of 0 or 1
Measured: 8 weeks
To evaluate the effect of CP101 on induction of endoscopic remission
Mayo endoscopy sub-score of 0 or 1
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Sep 2023
- Primary completion21 Nov 2024
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Ravikoff Allegretti, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852574
- Sponsor's protocol ID
- 2023P001470
- Status last verified
- Dec 2024
- First submitted
- 2 May 2023
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CP101 for the Treatment of Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05852574
- Acronym / sponsor ID
- 2023P001470
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 21 Nov 2024 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This dose ranging exploratory phase 1 pilot study will assess engraftment, safety, and efficacy of CP101, an oral microbiome therapeutic, in participants with active mild-to-moderate UC.
Participants with mild-moderate disease, defined as a complete Mayo score of ≥4 to ≤9 will be eligible for enrollment. Eligible participants must have an endoscopic and
histologically confirmed diagnosis of mild-to-moderate UC. Participants must have active disease at endoscopy (Mayo endoscopic score<=1) performed during screening.
Participants who meet eligibility criteria will be randomized 1:1 to either initial induction only or initial and extended induction dosing with CP101. Both arms will receive an initial induction dose of CP101 comprising 10 capsules daily for 5 days. Participants will then either receive extended induction with a daily dosing of five CP101 capsules through Week 8 or matching placebo. Both participants and PI will be blinded to treatment arm allocation.
Participants will be assessed through Week 8 for the primary outcome, engraftment. Safety outcomes (all AEs and safety laboratory values) will be assessed through the 8 week treatment period. In addition, secondary efficacy outcomes of disease remission and response will be evaluated at Week 8. Participants will also be followed through Week 24 for long-term safety, engraftment, and clinical outcomes (including but not limited to remission and response). AEs will be recorded from informed consent through Week 24 trial visit. Blood samples for safety laboratory analysis, as well as blood and stool samples for biomarker assessments will be collected at scheduled trial visits per the Schedule of Assessments.
The primary outcome, engraftment of CP101 associated microbes will be measured utilizing two baseline samples (prior to CP101 administration) and the participant's Week 8 stool sample following Randomization. Additional stool sample collections for microbiome assessment will occur at Day 6, Week 4, 8, 12, 16, and 24.
Participants that experience on-study worsening of their UC or a severe flare requiring the administration of rescue therapy, will be withdrawn from the study but not replaced. They will be considered treatment failures and last values collected will be carried forward.
This study will prospectively enroll approximately 30 adult participants at a single center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CP101 | Experimental | Drug: CP-101Extended 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. |
| CP101 + Placebo | Placebo comparator | Drug: CP-101 + PlaceboShort 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent
- Male or female ≥18 years of age
- Ulcerative colitis diagnosed by routine clinical, radiographic, endoscopic criteria
- 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)
- 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.)
Key exclusion criteria (20 listed)
- Severe or refractory UC defined as Mayo score ≥10
- Disease limited to distal proctitis
- Fever > 38.3°C
- Known history of Crohn's disease or indeterminate colitis
- Inability to ingest capsules (e.g., severe nausea, vomiting, gastroparesis, gastric outlet obstruction, dysphagia and/or history of chronic aspiration).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP-101CP101 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 | CP101 |
| CP-101 + PlaceboThe 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 | Drug | CP101 + Placebo |
Primary outcome
To evaluate engraftment of CP101-associated microbes after extended induction compared to the short induction arm
Time frame: 8 weeks
Quantification of CP101-associated taxa following administration of CP101 that were absent at baseline (pre-CP101 administration)
To evaluate the safety and tolerability of CP101
Time frame: 8 weeks
Subject incidence of treatment-emergent adverse events (including treatment-emergent adverse events for clinically significant changes in laboratory parameters and vital signs)
3 secondary outcomes
To evaluate the effect of CP101 on induction of clinical remission
Time frame: 8 weeks
To evaluate the effect of CP101 on induction of clinical response
Time frame: 8 weeks
To evaluate the effect of CP101 on induction of endoscopic remission
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CP-101 in people with Ulcerative Colitis, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate engraftment of CP101-associated microbes after extended induction compared to the short induction arm (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.