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.
- To learn more about the IBD-AID diet, you can read more here.
- Meet the Study Team
- Frequently Asked Questions
- Contact Us
Who is eligible to participate?
- Any woman who is currently pregnant (less than 30 weeks) or planning to become pregnant.
- You may or may not have CD or UC.
If you have CD or UC, you may choose whether to follow the IBD-AID diet or your regular diet.
There are 3 groups of participants in this trial:
- Women with CD/UC following diet intervention
- Women with CD/UC following their usual diet
- Women without CD/UC following their usual diet
What does participation involve?
During third trimester of pregnancy:
- Collection of maternal stool and saliva samples at home
- Completion of health history questionnaires
- Weekly web-based diet assessments between weeks 27 and 37
- 3 phone-based diet assessments
- Collection of umbilical cord blood and meconium (baby’s first stool)
- Questionnaire about your delivery
- Collection of baby’s stool at 14, 30 and 90 days, and 6 and 12 months after birth
- Collection of maternal stool and saliva samples at 6 and 12 months after birth
- Collection of breast milk (if breast-feeding)
- Completion of diet assessment questionnaires through phone calls with the research team
- Optional DNA saliva sample for sequencing
Frequently Asked Questions
Is there any cost of travel required to participate?
There is no cost or travel required to participate. All samples are clinical information can be collected by mail or over the phone. We will provide everything needed to collect and ship the samples.
How long will my participation last?
Your participation will last from the beginning of your third trimester through your baby’s first birthday.
Is there compensation for participation?
Participants will be compensated up to $900, which is paid in installments throughout the study period.
Do you need to be local to participate?
No, you do not need to live in New York City to participate. Anyone in the United States can participate.
At what timepoint during my pregnancy can I enroll?
You can enroll at any timepoint before week 30 of your pregnancy.
Is there any risk involved?
There is no risk involved in the collection of stool, saliva, umbilical cord blood, and breast milk. Your samples will be immediately de-identified upon receipt. The diet intervention has been adapted for safety in pregnancy.