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Study of Dietary Composition in Crohn's Disease

About

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 compared with the usual diet, to produce favorable changes in these multi-omics profiles. These findings will provide insight into the interactions between diet and host biology, while providing clues on the mechanisms of diet therapy's effect and CD pathogenesis.

Primary Purpose
Prevention
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
75 Years

Inclusion Criteria:

  • Age of 18 to 75 years old
  • History of Crohn's Disease (CD) with mild to moderate symptoms and prior biopsy proof

Exclusion Criteria:

  • 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.

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Study Stats
Protocol No.
20-001120
Category
GI Disorders
Contact
Gail Thames
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04431700
For detailed technical eligibility, visit ClinicalTrials.gov.