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Diet as Essential Therapy (DIET) for Inflammatory Bowel Disease

NCT03012542 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-05-17

No results posted yet for this study

Summary

Recent data suggest that diet in inflammatory bowel disease (IBD) may lead to both symptom control and disease remission. Historically certain diets have been recommended for patients with Crohn's disease during exacerbations despite lack of data supporting efficacy. The investigators propose to evaluate two such diets by randomizing 32 subjects with mildly to moderately active Crohn's disease to one of two diets that differ in the amount and type of carbohydrates and fiber. Subjects will remain on the diet for 8 weeks and will be evaluated for changes from baseline in inflammatory biomarkers, symptomatic disease activity, and the microbiome.

Conditions

  • Crohn Disease

Interventions

DIETARY_SUPPLEMENT

Diet 1

Diet controlled in amount and source of carbohydrates or fiber containing foods.

DIETARY_SUPPLEMENT

Diet 2

Diet controlled in amount and source of carbohydrates or fiber containing foods.

Sponsors & Collaborators

Principal Investigators

  • Timothy L Zisman, MD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-09-30
Completion
2019-12-31

Countries

  • United States

Study Locations

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Entities

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 NCT03012542 on ClinicalTrials.gov