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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01926730
Other study ID # K24-DK078228-FACES
Secondary ID K24DK078228
Status Completed
Phase N/A
First received August 18, 2013
Last updated February 13, 2017
Start date November 2013
Est. completion date June 2016

Study information

Verified date February 2017
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed study is a randomized controlled trial of a limited restriction diet compared to a regular diet among patients with Crohn's disease (CD) in remission. At baseline, patients will complete a semi-quantitative food frequency questionnaire assessing usual dietary patterns over the preceding month. Disease activity will be assessed with the abbreviated Crohn's Disease Activity Index (aCDAI)59. Self-reported disease status will be assessed during follow-up using an internet-based questionnaire. Repeat assessment of adherence to the study diets will be assessed with food frequency questionnaires (FFQs) administered after 20 weeks. Follow-up duration will be for 48 weeks. Statistical analysis will compare the time to relapse using Cox regression for patients in the two study arms. In the exploratory aim, we will compare outcomes among patients in the highest tertile for other food items and nutrients to those in the lowest tertile based on self-reported usual dietary patterns at baseline. Thus, the study population will be analyzed both as a randomized controlled trial and as a prospective cohort study.


Recruitment information / eligibility

Status Completed
Enrollment 216
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Patients must have an established diagnosis of CD.

2. All patients must be in clinical remission at the time of entry into the study. Remission is defined as an aCDAI of less than 150.

Exclusion Criteria:

Inflammatory bowel disease (IBD) unspecified / Indeterminate colitis

Total or sub-total colectomy, ileostomy, or colostomy

Unable to read and speak English

No internet access

Steroids other than budesonide =6mg/day with the prior two weeks

Perianal fistula or abscess with more than scant drainage

Age less than 18 years

Pregnant or breastfeeding women

Unwilling to follow the study diet

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Restriction diet
Selected food items will be limited in the participants diet

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
University of Pennsylvania Crohn's and Colitis Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relapse of Crohn's Disease (CD) Relapse of CD is defined as an increase in the aCDAI by >=60 points and to >150. Additionally, undergoing CD surgery or starting any new CD medication (steroids, mesalamine, azathioprine, methotrexate, anti-Tumor Necrosis Factor a (anti-TNF), anti-a4) for the treatment of CD symptoms during the interval between two visits will be considered to have identified a clinical relapse. Every 8 weeks during the 48 week study period
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