Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diet as Essential Therapy (DIET) for Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03012542
Recruitment Status : Unknown
Verified May 2018 by Timothy Zisman, University of Washington.
Recruitment status was:  Recruiting
First Posted : January 6, 2017
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Timothy Zisman, University of Washington

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.

Condition or disease Intervention/treatment Phase
Crohn Disease Dietary Supplement: Diet 1 Dietary Supplement: Diet 2 Not Applicable

Detailed Description:

Subjects will be randomized in a 1:1 ratio to receive one of two diets that are thought to be beneficial for Crohn's disease for a period of 8 weeks.

Initial evaluation will include a clinic visit with physical exam, medication review, supplemental documentation, and labs. Patients will be asked about their food allergies and intolerances against a master list of all ingredients used in both diets. Patients will then be provided with instructions on how to record their baseline dietary intake for two weeks prior to the intervention diet.

At day 0 patients will begin their study diet. All study meals will be provided to the subject and an approved snack list for the randomized diet will be provided in a sealed envelope with their first week of meals.

At the conclusion of intervention patients will be asked to resume their previous diet for 4 weeks and record their dietary intake. Stool and blood will be collected at baseline and at 4, 8, and 12 weeks. At the conclusion of the study patients will be told which diet they were on and will be provided with dietary consultation by a registered dietitian.

Subjects who withdraw from the study before the 4 week assessment will be asked to provide a final stool sample at the time of withdrawal. If more than 2 subjects drop out prior to week 4, subject replacement will occur.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Diet for Crohn's Disease and Impact on Disease Activity and the Microbiome
Study Start Date : January 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Diet 1
Administered for 8 weeks.
Dietary Supplement: Diet 1
Diet controlled in amount and source of carbohydrates or fiber containing foods.

Experimental: Diet 2
Administered for 8 weeks.
Dietary Supplement: Diet 2
Diet controlled in amount and source of carbohydrates or fiber containing foods.




Primary Outcome Measures :
  1. Fecal Calprotectin Remission [ Time Frame: 8 weeks ]
    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


Secondary Outcome Measures :
  1. Fecal Calprotectin Response [ Time Frame: 8 weeks ]
    Calprotectin response (decrease by ≥ 100 points) or calprotectin improvement (decrease by > 50%) at weeks 4 and 8 for subjects on each diet. Comparison of the mean calprotectin between the 2 treatment groups.

  2. Clinical Response [ Time Frame: 8 weeks ]
    Proportion of patients on each diet with clinical response (HBI score decrease by ≥ 3) or remission (HBI score < 5) at weeks 4 and 8

  3. Metagenomics [ Time Frame: 8 weeks ]
    To compare changes in the metagenomics of the fecal microbiome at 8 weeks relative to baseline for each diet

  4. Microbiota correlation with clinical disease activity and inflammatory biomarkers [ Time Frame: 8 weeks ]
    To determine if changes in the microbiota are associated with changes in clinical disease activity (HBI score), or inflammatory biomarkers (fecal calprotectin, C-reactive protein, etc.).

  5. Future Use [ Time Frame: 8 weeks ]
    To collect stool and blood for potential future analysis looking at proteomics and metabolomics.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012542


Contacts
Layout table for location contacts
Contact: Timothy L Zisman, MD, MPH 206-543-3220 tzisman@medicine.washington.edu
Contact: Christopher J Damman, MD 206-543-3220 cdamman@medicine.washington.edu

Locations
Layout table for location information
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Andrea Martin    206-543-3220    amartin@medicine.washington.edu   
Sponsors and Collaborators
University of Washington
Investigators
Layout table for investigator information
Principal Investigator: Timothy L Zisman, MD, MPH University of Washington
Publications:
Layout table for additonal information
Responsible Party: Timothy Zisman, Associate Professor of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT03012542    
Other Study ID Numbers: STUDY00003247
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Requests from investigators will be evaluated on a case by case basis. Data that may be shared include lab values, patient reported outcomes, questionnaires, and microbiome sequences. Specimens may also be shared. Researchers can request data from the study's Principal Investigator in writing.
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases