Ignite Creation Date:
2024-05-06 @ 2:48 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04431700
Status:
RECRUITING
Last Update Posted:
2023-05-06
First Post:
2020-06-04
Brief Title:
Study of Dietary Composition in Crohns Disease
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Impact of Anti-Inflammatory Whole-Food Diet in Crohns Disease and Predicting Response to Therapy
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CD
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 therapys effect and CD pathogenesis
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 Crohns 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None