A Crohn's Disease Diet to Reduce Symptoms of Crohn's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Johns Hopkins University
Sponsor:
Collaborator:
The Broad Foundation
Information provided by (Responsible Party):
Gerard E. Mullin, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01897090
First received: July 8, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  Purpose

A 16-week randomized, pilot study to determine if an elimination diet reduces symptoms of Crohn's disease. Sixty (60) adult patients (18-75 yrs) with a mild or moderate Crohn's Disease Activity Index (CDAI) of 150-450, will be recruited through the GI practices at Johns Hopkins University. Patients agree not to be on any other major treatments, with the exception of consistent/stable doses of 5-aminosalicylate (ASA) drugs/other medications during the course of the study and will obtain their physician's permission.They will be divided into a treatment and standard diet group: thirty (30) patients will be on the "Crohn's Disease Diet" (primarily an "anti-inflammatory diet that is an elimination diet - gluten-free, casein-free based with limited carbohydrate) and thirty (30) patients will be given the Dietary Guideline recommendations and similar dietary counseling attention. To assess the clinical efficacy and tolerance of the trial population, patients will be monitored by two office visits (at 0 and 12 weeks) by visits with the Clinical Research Unit (CRU) registered dietitians (RDs) at 0, 6, 12, and 16 weeks (4 weeks after the end of the study) for blood and dietary data collection. Clinical endpoints will be Crohn's disease Activity Index (CDAI) scores (remission < 150; mild = 150-220; moderate = 220-450; severe = 450+), C-Reactive Protein (CRP) values (0-0.8 mg/L), sedimentation rate /(male: 15-20 mm/hr, female: 20-30 mm/hr)/, possibly interleukin-6(/normal value: <10pg/ml)/, Overall Quality of Life (QOL) through the Inflammatory Bowel Disease Questionnaire (IBDQ), Dudley IBD Symptom Questionnaire (DISQ) surveys, and Brown's Gastrointestinal Quality of Life (QOL) Questionnaire, and health care costs measured by a health care cost questionnaire.


Condition Intervention
Crohn's Disease
Other: Elimination Diet
Other: Dietary Guidelines for Americans

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Relationship of a "Crohn's Disease Diet" in Reducing Symptoms of Crohn's Disease, Improving Quality of Life, and Decreasing Related Health Care Costs.

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • CDAI score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Clinical endpoints will be Crohn's disease Activity Index (CDAI) scores (remission < 150; mild = 150-220; moderate = 220-450; severe = 450+),


Secondary Outcome Measures:
  • CRP [ Time Frame: 16 WEEKS ] [ Designated as safety issue: No ]
    C-Reactive Protein (CRP) values (0-0.8 mg/L)

  • sed rate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    sedimentation rate (male: 15-20 mm/hr, female: 20-30 mm/hr)

  • Quality of Life [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Score on short inflammatory bowel disease questionniare (SIBDQ) and Brown's GI Quality of Life measure

  • Symptom improvement [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Score of DISQ


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elimination Diet
thirty (30) patients will be on the "Crohn's Disease Diet" (primarily an "anti-inflammatory diet that is an elimination diet - gluten-free, casein-free based with limited carbohydrate)
Other: Elimination Diet
Active Comparator: Dietary Guidelines for Americans
The DASH eating plan is based on 1,600, 2,000, 2,600 and 3,100 calories.
Other: Dietary Guidelines for Americans

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 18 and 75 years of age with any gender.
  • Between 150-220 or moderate Crohn's Disease with a CDAI between 220-450.
  • Not a smoker.
  • No current signs or symptoms of severe, progressive or uncontrolled renal, gastroenterological, hepatic, hematological, endocrine, pulmonary, cardiac, neurological or cerebral disease.
  • Understand and be able to adhere to the dosing and visit schedules; and agree to record symptom severity scores, any medications or dietary supplements, and adverse events accurately and consistently in a daily diary.
  • Agree during the study to use only the designated therapy, however, patients will qualify for the study if they are on a 3-month stable dose of 5-ASA or immunomodulators and there is a limited change in medication dosage no minimize biasing the results.
  • Agree that you have not previously followed diets where you have eliminated an allergen, lactose, gluten or major food group for the purpose of reducing Crohn's disease symptoms within the last year.
  • Agree not to use any oral medications, dietary supplements, herbal treatments, diet therapies within three weeks of the onset of the trial or during the study. During the study agree to use only the designated therapy, however, patients will qualify for the study if they are on a 3-month stable dose of 5-aminosalicylic acid (ASA) or immunomodulators and there is a limited change in medication dosage no minimize biasing the results.
  • Willing to follow the diet during the study and to weigh themselves weekly.

Exclusion Criteria:

  • Have extensive colonic, ileal or ileocolonic resection, ileostomies or colostomies with ileal pouch.
  • Experiencing severe weight loss (if % of weight change within 1 week >2% or 1 month >5% or 3 months >7.5% or 6 months > 10%) or severely malnourished (if < 74% of usual body weight).
  • Pregnant, lactating woman or desire to become pregnant during the study. [ ] [ ] Patients receiving prescribed oral nutrition and/or intravenous nutrition.
  • Presence of alcohol, drug abuse, or smoking (cigarette or other).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01897090

Contacts
Contact: Gerard Mullin, MD 410-502-4270 gmullin1@jhmi.edu
Contact: Sharon Dudley-Brown, PhD 410-502-4646 sdudley2@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Gerard Mullin, MD    410-502-4270    gmullin1@jhmi.edu   
Principal Investigator: Gerard Mullin, MD         
Sub-Investigator: Sharon Dudley-Brown, PhD         
Sponsors and Collaborators
Johns Hopkins University
The Broad Foundation
  More Information

Additional Information:
Publications:
Responsible Party: Gerard E. Mullin, Associate Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01897090     History of Changes
Other Study ID Numbers: NA_00042692
Study First Received: July 8, 2013
Last Updated: July 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Elimination Diet
Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on October 01, 2014