The MELODY Trial

What is the MELODY Trial?

The MELODY Trial will test whether a non-invasive diet intervention during the third trimester of pregnancy can beneficially shift the bacterial flora of the body, or the microbiome, in patients with Crohn’s Disease (CD) or Ulcerative Colitis (UC) and in their babies.

Crohn’s Disease (CD), a type of inflammatory bowel disease (IBD), is a chronic condition of the gastrointestinal tract that is associated with an imbalance in the gut microbiome (the makeup of bacteria in the stomach). Ulcerative Colitis (UC) is an inflammatory bowel disease that causes long-lasting inflammation and ulcers (sores) in your digestive tract. Diet may play a role in the development and treatment of CD and UC. Growing evidence suggests that maternal health and diet during pregnancy have an impact on the baby’s microbiome. This is important as the early life microbiome informs the immune system development, with long-term health consequences, including an increased risk of CD or UC and other diseases caused by weakening of the immune system.

By changing the maternal microbiome during pregnancy through diet, we hope to be able to promote healthier immune system development in infants born to mothers with CD or UC.

And we want to extend a thank you to the Leona M. and Harry B. Helmsley Charitable Trust for Funding the MELODY Trial.

More information


Olendzki, B. C., Hsiao, B. S., Weinstein, K., Chen, R., Frisard, C., Madziar, C., Picker, M., Pauplis, C., Maldonado-Contreras, A., & Peter, I. (2023). Dietary Intake of Pregnant Women with and without Inflammatory Bowel Disease in the United States. Nutrients, 15(11), 2464.

Peter, I., Maldonado-Contreras, A., Eisele, C., Frisard, C., Simpson, S., Nair, N., Rendon, A., Hawkins, K., Cawley, C., Debebe, A., Tarassishin, L., White, S., Dubinsky, M., Stone, J., Clemente, J. C., Sabino, J., Torres, J., Hu, J., Colombel, J. F., & Olendzki, B. (2020). A dietary intervention to improve the microbiome composition of pregnant women with Crohn’s disease and their offspring: The MELODY (Modulating Early Life Microbiome through Dietary Intervention in Pregnancy) trial design. Contemporary clinical trials communications, 18, 100573.

Contact our Research Coordinators at 347-620-0210 or for more information!