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

Crohn's Disease Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01897090
• Other study ID #: NA_00042692
• Status: Withdrawn
• Phase: N/A
• First received: July 8, 2013
• Last updated: April 4, 2016
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: April 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Other:
• Elimination Diet

• Dietary Guidelines for Americans

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	The Broad Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

Brown AC, Rampertab SD, Mullin GE. Existing dietary guidelines for Crohn's disease and ulcerative colitis. Expert Rev Gastroenterol Hepatol. 2011 Jun;5(3):411-25. doi: 10.1586/egh.11.29. Review. — View Citation

Brown AC, Roy M. Does evidence exist to include dietary therapy in the treatment of Crohn's disease? Expert Rev Gastroenterol Hepatol. 2010 Apr;4(2):191-215. doi: 10.1586/egh.10.11. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CDAI score	Clinical endpoints will be Crohn's disease Activity Index (CDAI) scores (remission < 150; mild = 150-220; moderate = 220-450; severe = 450+),	16 weeks	No
Secondary	CRP	C-Reactive Protein (CRP) values (0-0.8 mg/L)	16 WEEKS	No
Secondary	sed rate	sedimentation rate (male: 15-20 mm/hr, female: 20-30 mm/hr)	16 weeks	No
Secondary	Quality of Life	Score on short inflammatory bowel disease questionniare (SIBDQ) and Brown's GI Quality of Life measure	16 weeks	No
Secondary	Symptom improvement	Score of DISQ	16 weeks	No

External Links

•   The Broad Foundation