Diet as Essential Therapy (DIET) for Inflammatory Bowel Disease

NCT03012542 | Unknown

• 1 other identifier: STUDY00003247
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Fecal Calprotectin Remission

  To compare the proportion of patients with calprotectin remission (fecal calprotectin level \< 250 and a decrease by ≥ 100 points) at 8 weeks post-dietary intervention for subjects on each diet

  8 weeks

Secondary Outcomes (5)

• Fecal Calprotectin Response

  8 weeks

• Clinical Response

  8 weeks

• Metagenomics

  8 weeks

• Microbiota correlation with clinical disease activity and inflammatory biomarkers

  8 weeks

• Future Use

  8 weeks

Study Arms (2)

Diet 1

EXPERIMENTAL

Administered for 8 weeks.

Dietary Supplement: Diet 1

Diet 2

EXPERIMENTAL

Administered for 8 weeks.

Dietary Supplement: Diet 2

Interventions

Diet 1 DIETARY_SUPPLEMENT

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

Diet 1

Diet 2 DIETARY_SUPPLEMENT

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

Diet 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

Related Publications (5)

• Hou JK, Abraham B, El-Serag H. Dietary intake and risk of developing inflammatory bowel disease: a systematic review of the literature. Am J Gastroenterol. 2011 Apr;106(4):563-73. doi: 10.1038/ajg.2011.44.

  PMID: 21468064 BACKGROUND

• Richman E, Rhodes JM. Review article: evidence-based dietary advice for patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2013 Nov;38(10):1156-71. doi: 10.1111/apt.12500. Epub 2013 Sep 17.

  PMID: 24102340 BACKGROUND

• Wu GD, Chen J, Hoffmann C, Bittinger K, Chen YY, Keilbaugh SA, Bewtra M, Knights D, Walters WA, Knight R, Sinha R, Gilroy E, Gupta K, Baldassano R, Nessel L, Li H, Bushman FD, Lewis JD. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011 Oct 7;334(6052):105-8. doi: 10.1126/science.1208344. Epub 2011 Sep 1.

  PMID: 21885731 BACKGROUND

• David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.

  PMID: 24336217 BACKGROUND

• Manichanh C, Borruel N, Casellas F, Guarner F. The gut microbiota in IBD. Nat Rev Gastroenterol Hepatol. 2012 Oct;9(10):599-608. doi: 10.1038/nrgastro.2012.152. Epub 2012 Aug 21.

  PMID: 22907164 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Timothy L Zisman, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy L Zisman, MD, MPH

CONTACT

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

Christopher J Damman, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 6, 2017
• Study Start: January 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 17, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)