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The MELODY Trial: Modulating Early Life Microbiome through Prenatal Diet in Crohn’s Disease

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Aim 1: Design and implement a dietary intervention trial of CDED in pregnant women with CD. The goal is to recruit 70 pregnant women with CD randomized into CDED+calcium versus no diet and 35 age- and race/ethnicity-matched controls not assigned to the diet. 30-32 week pregnant study participants randomized to the CDED intervention arm will be guided to use a modified stage 1 CDED for 7 weeks. Serial stool samples along with detailed demographic, clinical, obstetrics and dietary intake information will be collected before, during and after the trial. Both mothers and their babies will be followed up with biospecimen and data collection for up to 1 year.
Aim 2: Estimate the effect of the diet on the changes in the pregnancy microbiome and postpartum clinical outcomes. We will compare the microbiome composition before (baseline) and after the intervention between the CD patients who received the diet, those who did not, and the controls using the 16S rRNA sequencing survey. We expect that the relative abundance of Bifidobacteria will go up and that of Proteobacteria go down in pregnant CD patients who received CDED as compared to CD oatients who did not receive the intervention, and will resemble the microbiota composition of control subjects. We will also explore if CDED reduces the risk of a composite 1-year postpartum disease relapse. All analyses will be adjusted for maternal age, disease duration, location, and medications.
Aim 3: Assess the effect of the diet on the development of the early life microbiome. Given our preliminary data showing that babies born to mothers with IBD have more pro-inflammatory microbiota up to at least 3 months of life and have higher levels of FC at year 1 compared to control babies, we will investigate if the dietary intervention during pregnancy is associated with a more balanced microbiome in the offspring. We will use cross-sectional and longitudinal analyses of repeated samples collected at numerous time points (7 days, 30 days, 90 days, 6 months, and 1 year). We will also explore the effect of maternal diet on baby’s functional gastrointestinal disorders (colic and regurgitation) and FC levels at year 1. All analyses will be adjusted for mode of delivery, feeding behavior, antibiotic exposure, and time of introduction of solid foods. In exploratory analyses, we will test particular bacterial strains and metabolomics biomarkers that are associated with the most and least response to the dietary intervention.

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ISSM\Hemsley 2019PF-CD010

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