Recruiting

DIET

Sponsor:

University of Washington

Code:

NCT03012542

Conditions

Crohn Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diet 1

Diet 2

Study Details

Brief 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

Study ID

NCT03012542

Start date

Jan, 2017

Status verified date

May, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Sep, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Consentable adults of age 18 or older.
  • Diagnosis of Crohn's disease made by a primary gastroenterologist based upon history, physical exam, laboratory/radiological studies, and endoscopy with biopsy.
  • Fecal Calprotectin ≥ 300
  • Mild to moderate disease activity based upon a modified Harvey Bradshaw Index score of 5-16.
  • On stable medication doses for ≥ 2 months.

Exclusion Criteria:

  • Inability/unwillingness to adhere to dietary recommendations.
  • Allergy or intolerance to any major component of the diets. Major component defined as an ingredient which, when left out of intervention diets, may affect study outcomes.
  • Allium intolerance
  • Exclusively vegetarian diet
  • Active intra-abdominal or perianal abscess/fistula
  • Symptomatic bowel stricture
  • Other serious medical conditions such as neurological, liver, kidney, autoimmune, or systemic disease
  • Use of corticosteroids within 1 month prior to baseline visit
  • Tobacco, alcohol, or illicit drug abuse
  • Pregnant subjects
  • Celiac disease
  • Patients already on one of the diets being studied
  • C. difficile or other enteric infection (O\&P, stool enterics)
  • Antibiotic use within 2 months prior to baseline visit

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Diet 1

Administered for 8 weeks.

experimental: Diet 2

Administered for 8 weeks.

Interventions

Diet 1

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

Diet 2

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

Primary outcome measure

  • Fecal Calprotectin Remission [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Timothy L Zisman, MD, MPH

206-543-3220tzisman@medicine.washington.edu

Christopher J Damman, MD

206-543-3220cdamman@medicine.washington.edu

Locations

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Andrea Martin

206-543-3220amartin@medicine.washington.edu

More Information

Sponsor

University of Washington

Last update posted

May 17, 2018

Last verified

May, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2018-05-17.