Study of Dietary Composition in Crohn's Disease

Crohn Disease Clinical Trial

— CD  

Official title:

Impact of Anti-Inflammatory Whole-Food Diet in Crohn's Disease and Predicting Response to Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04431700
• Other study ID #: 20-001120
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2023
• Source: University of California, Los Angeles
• Contact: Gail Thames
• Phone: 310-825-0453
• Email: Gthames[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 whole food diet will be compared to participants usual diet for understanding its effects on achieving clinical remission, clinical response, reduction in serological and fecal markers of inflammation, and improvement in patient-reported outcomes, such as physical activity, anxiety, depression, fatigue, pain, sleep disturbance, social satisfaction, and quality of life. The study will involve collection of blood and fecal specimens to evaluate the effects of the anti-inflammatory diet on the gut microbiome, bacterial metabolome, innate immune markers, and fecal microRNA profiles. The participants will be placed on anti-inflammatory diet for 8 weeks and assessed every 2 weeks for adherence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: May 1, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

1. 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

2. Recent hospitalization within the last 30 days

3. Currently pregnant of lactating.

4. Current use probiotics or dietary supplements that would not be willing to discontinue for the length of the study.

5. Concerns for non-compliance

6. 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.

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases

Intervention

Other:
• Anti-inflammatory diet
Anti-inflammatory diet with increased vegetables, fruit, plant polyphenols, lean proteins, foods rich in omega-3s and unsaturated fats as well as decreased in processed refined foods.
• Regular diet
Focus on food journal and recording all food intake.

Locations

Country	Name	City	State
United States	UCLA Center for Human Nutrition, 1000 Veteran Ave.	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the anti-inflammatory whole food diet for the induction of remission in Crohn's Disease	The patients' clinical response, defined by the Harvey-Bradshaw Index (HBI) (5 through 16 points) for clinical symptom improvement and/or remission.	8 weeks