Bacterial Transmission In Utero and IBD Risk (The MECONIUM Study)
Published: 07/14/2017
General Information:
Microbes that live inside the human body provide a wide range of functions that the human body lacks. However, they are also linked to diseases, such as Crohn's disease and ulcerative colitis (collectively called inflammatory bowel disease, or IBD). Recently, it has been shown that newborns carry bacteria transferred from their mothers. We would like to determine how and when maternal bacteria are transferred to a baby from mothers with and without IBD. This information can help us develop novel strategies to limit risk transmission from a mother to a baby.
Eligibility:
Eligibility Criteria:
- Women who are pregnant or wishing to become pregnant (with or without IBD)
- 18 years and older
Ineligibility Criteria:
- History of HIV
- Individuals who are not able to give informed consent
Study Details:
Patient Participation Requirements
From Mothers:
- Participation involves collection of stool and saliva from mothers before becoming pregnant and/or in each trimester of the pregnancy, depending upon time of enrollment. These samples can be collected at home and shipped to us with a prepaid shipping label that we will provide. At the time of sample collection, we will also ask for health status, health history, and dietary information. During the third trimester of pregnancy, there is an optional vaginal swab sample collection, coinciding with your routine Group B strep test. After your baby's birth, we will collect a breast milk sample if you are nursing your baby. Compensation of up to $400 is provided based on samples collected.
From Babies:
- When your baby is born, we will collect the baby's meconium, or first stool, and a buccal (cheek) swab, as well as optional cord blood and placenta samples. We will collect your baby's diapers containing stool at 7 days, 14 days, 30 days, 60 days, 90 days, 1 year, 18 months, and 2 years, and then a stool sample from the baby at 3 years, 4 years, and 5 years of age. We will also ask for information about your baby's delivery, diet, vaccinations, and health status.
From Family Members (optional):
- Participation involves a one-time stool and saliva collection from your baby's father or any siblings, if they would like to participate. We will also ask for information about their health status, health history, and diet at the time of sample collection. These samples are optional and can be collected at any time point before the baby's birth. Each family member will be compensated $25 for their participation.
Possible Risks & Side Effects
There are no risks to stool, saliva, placenta, umbilical cord blood, vaginal swab, and breast milk collection. Providing results or genetic information to you is not part of this study so the chance that participation in this study could cause psychological distress and economic and social harm is minimal. Your samples will be immediately de-identified, and the chance that your protected health information may be accidentally divulged to anyone other than the PI and her delegates is very small.