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Dietary Intervention

Specific Carbohydrate Diet (First) for Crohn's Disease (PRODUCE Trial)

N/A
Waitlist Available
Led By Heather C Kaplan, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, week 4, week 10, week 12 and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization)
Awards & highlights

PRODUCE Trial Summary

A series of N-of-1 trials will be used to determine the effectiveness of a specific carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and inflammatory burden at both the individual and population level. This is a four-year study. The study staff will recruit up to 60 patients across up to 21 sites in patients aged 7-18 with mild to moderate disease activity.

Eligible Conditions
  • Crohn's Disease
  • Inflammatory Bowel Disease
  • Ulcerative Colitis
  • Indeterminate Colitis

PRODUCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, week 4, week 10, week 12 and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, week 4, week 10, week 12 and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fecal Calprotectin
Gastrointestinal Symptoms
Pain Interference
+2 more
Secondary outcome measures
Growth
Laboratory markers of disease activity and inflammation
Pediatric Ulcerative Colitis Activity Index (PUCAI)
+2 more

PRODUCE Trial Design

2Treatment groups
Experimental Treatment
Group I: Specific Carbohydrate Diet (First)Experimental Treatment2 Interventions
Participants will be following the Specific Carbohydrate Diet (SCD). Allowed foods include meat/fish/poultry, eggs, some legumes (e.g., lentils and split peas are permitted, chickpeas and soybeans are not), fully fermented yogurt, non-starchy vegetables, ripe fruit, nuts/seeds, honey and nut flours (e.g. almond flour or coconut flour). Restricted foods include all grains, milk products aside from 24-hour fermented SCD yogurt and cheeses aged greater than 30 days, starchy vegetables, processed foods with food additives and sweeteners other than honey.
Group II: Modified Specific Carbohydrate Diet (First)Experimental Treatment2 Interventions
Participants will be following a modified Specific Carbohydrate Diet (MSCD). In addition to the foods in the SCD, allowed foods will expand to include organic rice, oats, sweet potatoes, grade A maple syrup and cocoa. Gluten, corn products, milk products (except yogurt and hard cheeses), sweeteners (except honey), and process foods are still restricted.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoOTHER
2,518 Previous Clinical Trials
15,241,675 Total Patients Enrolled
Seattle Children's HospitalOTHER
306 Previous Clinical Trials
5,218,343 Total Patients Enrolled
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,530,616 Total Patients Enrolled
~8 spots leftby Jun 2025
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