Scientists hunt for immune culprits behind Crohn's Flare-Ups after surgery
NCT ID NCT06006039
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to understand why Crohn's disease often returns after surgery by examining specific immune cells that respond to a protein called IL-23. Researchers will collect tissue samples from 40 patients with Crohn's disease during routine colonoscopies, before and after 12-16 weeks of standard biologic treatment. The goal is to identify which cell types drive inflammation, which could help develop better therapies in the future.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this research could reveal which immune cells are key targets for new Crohn's disease therapies, potentially leading to more effective treatments.
- What could go wrong
- This is a small, early-stage observational study (40 participants) designed to gather knowledge, not to test a treatment. It may not directly lead to new therapies.
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.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Nov 2027
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.
Who is studied
The study will be performed in CD patients with postoperative recurrence. Patients will be counselled prior to their routine endoscopy (typically 6-9 months after surgery). In practice, this will be approximately be between one and two weeks before the routine endoscopy. The investigators intend to evaluate 20-30 patients for this study and recruit 40 patients. The reason for this, is that there is a possibility that patients do not have enough inflammation (Rutgeerts ≤i2a) and therefore cannot be included.
- Ages
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18 years and older
- Sex
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Anyone
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: * Age \>/= 18 years; * Male or non-pregnant, non-lactating females; * Patients with postoperative recurrence at routine endoscopy 6-24 months following resection, defined by presence of ulcerations (endoscopic Rutgeerts' score \>i2a) in the neoterminal ileum; * In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements; * The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures. Exclusion Criteria: * Any conditions (eg, history of alcohol or substance abuse, or lack of compliance) which, in the opinion of the investigator, may interfere with the patient's ability to comply with study procedures; * Any condition in which one of the potential treatments are contraindicated in the opinion of the investigator (eg, cardiac failure class 3-4 according to the New York Heart Association \[NYHA\], multiple sclerosis, active infections). * Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer. * Currently participating or planning to participate in a study involving an investigational product. * Active or planned pregnancy during the study. * Prior diagnosis of dysplasia in the colon (excluding in resected adenomas). * History of malignancy in the 3 years prior to randomization except for non-melanoma skin cancer. * Received a biologic treatment between surgery and first endoscopy. * Positive Clostridium difficile toxin B in faeces. Patients who test positive can be treated per local practice and still enter the study if no longer than 4 weeks after the screening visit, they test negative for Clostridium difficile toxin B. * Presence of a stoma without ileocolonic anastomosis or pouch. * Active perianal abscess or draining fistula * ALT or AST \> 3x the upper limit of normal measured at screening * Increased risk of bleeding: coagulation disorder, use of anticoagulants and DOACs
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Amsterdam UMC
RECRUITINGAmsterdam, North Holland, 1105, Netherlands
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Mount Sinai
RECRUITINGToronto, Ontario, 1X5, Canada
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