The MELODY Trial: Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease
The purpose of this study is to test whether a non-invasive dietary intervention during the last trimester of pregnancy can beneficially shift the microbiome, or the bacterial flora of the body, in patients with Crohn’s disease and in their babies. Crohn's disease, a type of inflammatory bowel disease, is a chronic condition of the gastrointestinal tract that is associated with an imbalance in the gut microbiome. Diet may play a role in the development and treatment of Crohn's disease. Accumulating evidence suggests that maternal health and diet during pregnancy and early life have an impact on the baby’s microbiome composition and immune system development, with long-term health consequences, including establishing risk of developing Crohn's disease and other immune-mediated diseases. 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 Crohn's disease.
- Capacity to sign informed consent
- At least 18 years old
- Singleton pregnancy of less than 29 weeks gestation
- 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
- Antibiotic or steriod treatment at recruitment
- Scheduled cesarean section prior to gestational week 37
There are three groups of participants in this study; women with Crohn's disease may choose whether to participate in Arm 1 by following a diet intervention, or in Arm 2 by following their usual diet without making any changes, as part of a control group, and women who do not have Crohn's disease will participate in Arm 3 by following their usual diet. Participation for all three groups involves self-collection of stool and saliva samples from mothers during the third trimester and after their pregnancy, and from their newborn baby during the first year of life, as well as one-time breast milk and umbilical cord blood sample collection. In addition to sample collection, participants will complete detailed health history questionnaires and periodic diet assessments through phone calls with dietitians and online surveys, and diet coaching by study team dietitians is available for participants who choose to follow the diet.
Description of Treatment or Intervention (Mechanism of Action):
a. Participants who choose to participate in the intervention arm will be asked to follow, as best as they can, a specified diet derived from the Specific Carbohydrate Diet (SCD). Research has shown that IBD patients have an imbalance of gut bacteria, which contribute to bowel inflammation. This diet helps to restore balance between helpful and harmful bacteria while promoting good nutrition. The diet has been adapted for safety in pregnancy. We hope to show that the diet can alter the microbiome of women with Crohn's disease during their pregnancy, and promote development of a healthy microbiome in their newborn babies. 12. Patient Participation Requirements (you may also attach any surveys or questionnaires, etc. that may be helpful along with your description. Please check n/a if not applicable): a. Sample collection and surveys on pregnancy and IBD status. 13.Possible risks associated with participation in this study: a. Loss of confidentiality: Risk of loss of private information; this risk always exists, but there are procedures in place to minimize the risk. b. Genetic research: There is a Federal law called the Genetic Information Nondiscrimination Act (GINA). In general, this law makes it illegal for health insurance companies, group health plans, and most employers of over 15 people to discriminate against you based on your genetic information. However, it does not protect you against discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. c. Those participating in the diet intervention may require a larger time commitment to learn about the diet and may need to spend more time shopping for and preparing their food than they did before d. Participation may result in unforeseeable risks to you.