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

ID#: NCT03850600

Age: 18 years - 66+

Gender: Female

Healthy Subjects: Accepts Healthy Volunteers

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: January 30, 2019

End Date: January 01, 2023

Contact Information:
Inga Peter, PhD
Alexa Rendon
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.

Inclusion Criteria:

- Capacity to sign informed consent

- At least 18 years old

- Singleton pregnancy of less than 27-29 weeks gestation

- English-speaking

Exclusion Criteria:

- Inability to provide informed consent


- Multi-fetus pregnancy

- Fetal chromosomal or structural abnormalities

- Active infection (including chorioamnionitis or sepsis)

- Alcohol use disorder

- Diagnosis of diabetes, renal disease, or intrauterine growth restriction

- Non-English speaking

- Active perianal or extraintestinal disease

- Antibiotic or steroid treatment at recruitment

- Scheduled cesarean section prior to gestational week 37