Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been diagnosed with, or your doctor strongly suspects you have, moderate to severe Crohn's disease affecting the small intestine and/or large intestine, and your doctor plans to start you on a medication called infliximab.
• Your Crohn's disease diagnosis was made within the last 12 months (at the time infliximab treatment begins).
• You have never been treated with a biologic therapy (a specific type of medication that targets the immune system) before.
• If you have had Crohn's disease for a while and are currently having a flare-up: your symptoms have not improved after 4 weeks of trying a special diet or steroid treatment.
• If you have been newly diagnosed: your symptoms have not improved after 2 weeks of trying a special diet or steroid treatment.
• Blood or stool tests show signs of active inflammation in your body (confirm with trial site for specific values).
• Your body weight falls within a normal range for your age and sex (between the 5th and 95th percentile on standard growth/BMI charts).
• You have been on steroids or exclusive enteral nutrition (a liquid-only diet) for less than 2 weeks (or less than 4 weeks if you have established disease).
• You are able and willing to follow specific dietary recommendations as part of the trial.
• You are taking a stable dose of azathioprine or methotrexate (immune-suppressing medications) at the time of joining the trial.
• You are willing to also take part in a related research network study called CIDsCaNN.

Who may not be able to join:

• You started a special Crohn's diet (CDED), liquid-only diet, or steroids more than 2 weeks before the point of joining the trial.
• You have taken antibiotics in the last 2 months (except for a short course of less than 1 week taken between 1 and 2 months ago), or you have used laxatives in the past month (except as part of bowel preparation for a camera test before starting treatment).
• You have taken probiotic, prebiotic, or synbiotic supplements in the last month (note: foods containing these, such as yogurt, are generally allowed — confirm with trial site).
• You follow a strict vegetarian or vegan diet.
• You are assessed as being at high risk of malnutrition based on a standard scoring tool used for children (confirm with trial site).
• You have another known gut condition (other than irritable bowel syndrome), a food intolerance, or another long-term illness.
• You have had bowel surgery before joining the trial.
• You have severe disease around the anal area, or a type of Crohn's disease that causes narrowing or tunnelling through the bowel wall.
• You have been taking prednisone or prednisolone (steroid medications) for more than 2 weeks.
• You are currently pregnant or breastfeeding.
• You are already taking part in another research study.
• You are unable to give consent to participate (confirm with trial site regarding age or capacity requirements).

Important: Always verify eligibility with the trial site directly before applying.