Maternal Gut Microbiome (MGM) Study of Diet, the Gut Microbiome and Preterm Birth

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT02560246
Collaborator
March of Dimes (Other)
400
1
27.9
14.4

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether diet and the gut microbiome play a role in spontaneous preterm birth (SPTB), namely delivery of the fetus prior to 37 weeks gestation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    While dietary guidelines about intake of specific nutrients in pregnant women are well-established, surprisingly little is known about dietary eating patterns or nutritional risk factors for SPTB.

    In data from two large nationally-representative European studies, SPTB was predicted by a western diet, a finding confirmed by a smaller cohort in Australia. In a small cohort in Poland, intake of short- and medium-chain fatty acids was lower in women who had SPTB, and the placental-fetal transport of fatty acids was significantly different in SPTB cases. Furthermore, more than a single serving daily of either artificially-sweetened or sugar-sweetened beverages was also linked to SPTB. Low blood biomarker levels of antioxidant nutrients (ascorbic, vitamin E)7 and nutrients with an established anti-inflammatory role in health (omega 3 fatty acids,8 vitamin D9-11) have been suggested as potential nutrient modulators of SPTB. While these are very interesting findings, they do not explain whether these food patterns prevail in an urban U.S. population or why SPTB occurs. Furthermore, none of these potentially modifiable diet associations has been examined in the context of the entire series of physiological systems operating during pregnancy, namely diet, the gut microbiome, maternal plasma metabolome, placenta, and cord blood.

    There is biological rationale to assume that dietary components could modify the gut microbiome and the maternal plasma metabolome during pregnancy. Artificial sweeteners induce glucose intolerance through an alternation in the gut microbiota. Chronic ingestion of sugar-sweetened beverages also results in similar plasma metabolic abnormalities (gut microbiome measures were not reported). In animal models of high fat diet feeding (similar to western diet), addition of N3FA ameliorated the gut dysbiosis and reduced endotoxin production. Furthermore, in healthy volunteers, the investigators have recently linked typical dietary intake patterns with the gut microbiome. Dietary patterns of high protein and animal fat intake were predominantly associated with Bacteroides enterotypes, while carbohydrate intake was associated with Prevotella. While the microbiome composition changes rapidly after change in diet, the enterotype identity is resilient over time. The investigators followed these findings with another study comparing the extreme diets of vegans (no animal products) to the more typical mixed western diet pattern of omnivores, and extended the analytical approaches to include assessment of the plasma metabolome. By observing the microbiome and metabolome, the investigators were clearly able to distinguish with 91% accuracy whether a subject was vegan or omnivore. Furthermore, the investigators could determine metabolomic characteristics that were contributed by gut bacterial metabolism, but only in subjects with high plant food intake. These findings in healthy volunteers raise the possibility that gut microbial populations could interact with maternal tissues or plasma to produce an inflammatory state that might result in preterm parturition. Indeed, the alteration of the gut microbiota observed in the third trimester of pregnancy and its effects on host metabolism are supportive of this notion.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    400 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Maternal Gut Microbiome (MGM) Study of Diet, the Gut Microbiome and Preterm Birth
    Actual Study Start Date :
    May 4, 2015
    Actual Primary Completion Date :
    Aug 29, 2017
    Actual Study Completion Date :
    Aug 29, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Preterm Labor

    Singleton pregnancy between 20 0/7 36 6/7 weeks gestational age who is admitted with PTL or cervical insufficiency (Equal or greater than 2 cm dilated) or PPROM

    Term Labor

    Admitted to the hospital with spontaneous labor (regular contractions, cervical dilation) or spontaneous rupture of membranes

    Outcome Measures

    Primary Outcome Measures

    1. Preterm Birth [At time of delivery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Pregnant women receiving care in University of Pennsylvania Health System

    • Between 16-24 weeks gestation

    Exclusion Criteria:
    • Multiple gestation

    • Fetal chromosomal abnormality or major fetal anomaly

    • Intrauterine fetal demise

    • Maternal HIV

    • Chronic kidney disease

    • Transplant

    • Prior weight loss surgery

    • Vegan diet

    • Chronic use of immunosuppresive medications or steriods

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania
    • March of Dimes

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT02560246
    Other Study ID Numbers:
    • 822218
    First Posted:
    Sep 25, 2015
    Last Update Posted:
    May 2, 2018
    Last Verified:
    May 1, 2018
    Keywords provided by University of Pennsylvania
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 2, 2018