Clinical Trial

Early Life Microbiome and Diet in Crohn's Disease

Study Description

Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

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.

Additional Information

Official Study Title

The MELODY Trial: Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease

Clinical Trial ID

NCT03850600

ParticipAid ID

en5mYd