Status:
WITHDRAWN
A Crohn's Disease Diet to Reduce Symptoms of Crohn's Disease
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
The Broad Foundation
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01897090
Start Date
January 1 2013
End Date
January 1 2014
Last Update
April 5 2016
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287