Recruiting

Adding a Special Diet to Standard Crohn's Treatment in Children

Plain-English translation of NCT07314606 on ClinicalTrials.gov ↗ · Source last updated May 2026 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing whether adding a modified Crohn's disease exclusion diet (mCDED) to infliximab—a biologic medication that reduces inflammation—helps children with Crohn's disease get better results than medication alone. Children will be randomly assigned to either follow the special diet while starting their infliximab treatment, or to start infliximab without dietary changes. The study will track how well each approach works over one year.

Infliximab is already known to help treat Crohn's disease, but doctors want to know if adding a specific dietary approach at the very start of treatment could improve how well the medication works and help more children go into remission.

Do you qualify?

You likely qualify if…

you have been diagnosed with moderate-to-severe luminal Crohn's disease, with active inflammation shown by blood or stool tests
you are between 12 months and just under 18 years old (roughly), and were diagnosed within the past 12 months
your doctor has decided you need to start infliximab as your treatment
you have not responded well enough to dietary changes or steroid medications within the past 2–4 weeks
you are able and willing to follow dietary recommendations with support from a dietitian
you have a healthy body weight for your age and sex

You likely don't qualify if…

you have already taken biologic medications for Crohn's disease
you have had recent surgery on your bowel
you have severe complications like fistulas or strictures that go deeper into the bowel wall
you are a strict vegetarian or vegan
you have taken antibiotics in the past 2 months (with rare exceptions) or used laxatives in the past month

What participation looks like

You will visit the clinic multiple times over 16 months total. First, you'll have 4 months of baseline visits and testing before you're randomly assigned to a group. Then, over the next 12 months, you'll receive your regular infliximab infusions and either follow a special diet with help from a dietitian (intervention group) or continue eating normally while meeting with a dietitian to discuss your regular diet (control group). You'll complete food diaries, dietary recall interviews, and questionnaires at various time points to help researchers understand how well the diet works alongside your medication.

AI-generated summary from trial data · Jun 28, 2026 · Not medical advice

Trial locations(1 site)

Canada

The University of British Columbia, Vancouver, British Columbia