Plain-English translation of NCT04777656 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Crohn's Disease research guide →Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing whether a special diet called the Crohn's Disease Exclusion Diet (CDED) works better when added to your regular Crohn's disease medications, compared to taking medications alone. The study involves children and teenagers aged 6–17 who have active Crohn's disease despite being on standard treatments. Researchers will follow participants for 13 months to see if the diet helps prevent disease flare-ups.
Some young patients don't respond well enough to current medications, and many families are hesitant to use strong medications long-term because of potential side effects. Early evidence suggests that what we eat may play an important role in Crohn's disease, so this trial explores whether dietary changes could be a helpful addition to standard care.
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You will first enter a 2-month run-in phase where you follow the exclusion diet while continuing your regular medications (corticosteroids will be tapered and stopped). If your disease improves during this time, you will be randomly assigned to either continue the diet plus your medications, or stop the diet and return to unrestricted eating while staying on your medications. The study lasts 13 months total, and researchers will track how often your disease flares up in each group.
AI-generated summary from trial data · Jun 17, 2026 · Not medical advice
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