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

NCT03301311 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-06-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of California, San Francisco

    collaborator OTHER

  • Seattle Children's Hospital

    collaborator OTHER

  • Dayton Children's Hospital

    collaborator OTHER

  • Brown University

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Heather C Kaplan, MD · Children's Hospital Medical Center, Cincinnati

  • Lisa Opipari-Arrigan, PhD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-10
Primary Completion
2020-09-08
Completion
2020-09-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03301311 on ClinicalTrials.gov