Status:
TERMINATED
Study of Dietary Composition in Crohn's Disease
Lead Sponsor:
University of California, Los Angeles
Conditions:
Inflammatory Bowel Diseases
Crohn Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Patients with inflammatory bowel disease (IBD) often have narrowed microbial diversity and altered composition and function of the gut microbiome. We anticipate the anti-inflammatory diet, when compar...
Detailed Description
A randomized controlled trial of the anti-inflammatory whole food diet versus usual diet for the induction of remission in 104 adults with mild-to-moderate Crohn's Disease (CD). The anti-inflammatory ...
Eligibility Criteria
Inclusion
- Age of 18 to 75 years old
- History of Crohn's Disease (CD) with mild to moderate symptoms and prior biopsy proof
Exclusion
- History or current diagnosis of any of the following:
- Stroke or Arrhythmia
- Seizures
- Liver Disease
- Untreated hypertension (High Blood Pressure)
- Active malignancy
- Bleeding disorders
- Heart Disease
- Lung disease
- Previous Heart surgery
- Previous Gastrointestinal Surgery
- Kidney Disease
- Chronic Diarrhea
- End enterostomy
- Bulimia
- Anorexia
- Laxative Abuse
- Endocrine Disorder
- Current history of smoking tobacco
- Urgent need for abdominal sugery
- Severe Malnutrition
- Active alcohol or non-cannabinoid substance abuse
- Recent hospitalization within the last 30 days
- Currently pregnant of lactating.
- Current use probiotics or dietary supplements that would not be willing to discontinue for the length of the study.
- Concerns for non-compliance
- If currently on immunosuppressants, immunomodulators, cotticosteroids, and/or 5-aminosalicylates, no changes in doses will be permitted during the trial except for tapering of corticosteroids.
Key Trial Info
Start Date :
October 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04431700
Start Date
October 5 2020
End Date
March 31 2025
Last Update
December 18 2025
Active Locations (1)
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1
UCLA Center for Human Nutrition, 1000 Veteran Ave.
Los Angeles, California, United States, 90095