NCT03301311

Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease

Using Single Subject (N-of-1) Designs to Answer Patient-Identified Research Questions--Aim 1: Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Bowel Diseases
• Crohn Disease
• Ulcerative Colitis
• Indeterminate Colitis

Interventions

Type	Name	Description
OTHER	Specific Carbohydrate Diet (SCD)	Patients will be randomized to start with either a strict SCD or modified SCD. Participants will alternate between each diet in 8-week intervals for a total duration of approximately 34 weeks. Participants will complete two 8-week intervention periods on each diet.
OTHER	Modified Specific Carbohydrate Diet (MSCD)	Patients will be randomized to start with either a strict SCD or modified SCD. Participants will alternate between each diet in 8-week intervals for a total duration of approximately 34 weeks. Participants will complete two 8-week intervention periods on each diet.

Timeline

• Start date: 2018-04-10
• Primary completion: 2020-09-08
• Completion: 2020-09-08
• First posted: 2017-10-04
• Last updated: 2022-06-28

Locations

20 sites across 1 country: United States