Personalized Research on Diet in Ulcerative Colitis and 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

No Placebo-Only Group

Summary

This trial will look at how different diets can help reduce symptoms and inflammation in young patients. The goal is to see if changing their diet can better manage their condition.

Eligible Conditions

Ulcerative Colitis
Crohn's Disease
Inflammatory Bowel Disease
Colitis

Timeline

Screening ~ 3 weeks3 visits

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fecal Calprotectin

Gastrointestinal Symptoms

Pain Interference

+2 more

Secondary study objectives

Growth

Laboratory markers of disease activity and inflammation

Pediatric Ulcerative Colitis Activity Index (PUCAI)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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