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Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease
Sponsor: Icahn School of Medicine at Mount Sinai
Summary
The MELODY Trial: Modulating Early Life Microbiome through Dietary Intervention in Crohn's Disease, will test whether a non-invasive dietary intervention during pregnancy can improve the gut microbiota composition in both pregnant Crohn's disease patients and their babies during the sensitive time window of infant immune system development, and whether this can lead to decreased risk of maternal disease relapse postpartum and decreased functional gastrointestinal disorders and gut inflammation in their babies. Through this trial, the study team hopes to better understand the origin of the initial gut bacterial colonization in babies, providing potential intervention targets to prevent Crohn's disease development in high risk individuals.
Official title: The MELODY Trial: Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
194
Start Date
2019-01-30
Completion Date
2027-11
Last Updated
2025-02-06
Healthy Volunteers
Yes
Conditions
Interventions
Diet-CD
CD patients will self-select into the intervention arm to follow the diet for 8-10 weeks during their third trimester of pregnancy.
Locations (2)
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States