Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
21 participants
INTERVENTIONAL
2025-10-01
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participants with steroid-naïve irColitis
Participants with non-steroid refractory irColitis
KAN-004
Each dose of KAN-004 contains a consortium of bacteria isolated from the stool of healthy donors formulated as a powder in a capsule intended for oral administration
Interventions
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KAN-004
Each dose of KAN-004 contains a consortium of bacteria isolated from the stool of healthy donors formulated as a powder in a capsule intended for oral administration
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of irColitis (CTCAE \>grade 2).
* Age ≥18 years
* Able to ingest capsules.
* Consent to provide blood and stool samples.
* Accessible for treatment and follow-up.
* Agreement to use highly effective contraception if of childbearing potential.
Exclusion Criteria
* Colostomy.
* Prior diagnosis of malabsorption.
* Untreated chronic hepatitis B or C.
* Solid organ transplant recipients.
* HIV-positive status.
* Pregnancy or breastfeeding.
18 Years
ALL
No
Sponsors
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Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Responsible Party
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Principal Investigators
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Arielle Elkrief, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier de l'Universite de Montreal (CHUM)
Locations
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Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Countries
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Central Contacts
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Other Identifiers
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MP-02-2026-12952 (AE-KAN-004)
Identifier Type: -
Identifier Source: org_study_id
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