Cure8 trial brief
Why This Matters
Dietary patterns, especially ultra-processed food intake, are increasingly linked to Crohn's disease activity. This trial could provide randomized evidence on whether reducing ultra-processed foods prolongs remission in children and adolescents.
Who Should Pay Attention
Pediatric patients with Crohn's disease and their caregivers, pediatric gastroenterology clinicians and dietitians, and researchers studying diet-IBD relationships.
Study Snapshot
What To Know
This is a recruiting interventional randomized trial enrolling 10–18-year-olds with Crohn's disease who have been in clinical remission for at least three months. Participants are randomized 1:1 to a 12-month program of structured counseling focused on reducing ultra-processed foods (NOVA category 4) versus matched counseling on general healthy eating.
Both arms receive the same schedule of dietitian visits to keep attention balanced. The study will track clinical remission at 12 months (primary outcome), time to relapse, growth and nutritional status, iron and albumin levels, and safety.
Dietary intake and adherence are assessed with a modified Processed Food Questionnaire adapted for the pediatric Czech population. The intervention aims for gradual, sustainable shifts toward minimally processed foods while preserving adequate nutrition and normal growth.
What the record is not: This is a trial registration describing the study design and planned outcomes, not results. No efficacy or safety findings are reported here.
Keep In Mind
This is a trial registry entry describing a recruiting randomized study; it does not report results. The protocol emphasizes monitoring growth and nutritional adequacy because restrictive diets can risk malnutrition in children.
Source Details
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.