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CompletedNCT02560246MGMUpdated May 2, 2018

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

An observational study in Preterm Birth, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-02.

Sponsored by University of Pennsylvania · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Preterm Birth

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Keywords

  • Microbiome
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In context

Premature Birth

2,553 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 400 is above the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pregnant women will be recruited from three locations: Penn ObGyn Associates, Helen O. Dickens Clinic, and Maternal Fetal Medicine at 2000 Courtyard. Potential subjects will be identified from clinical schedules and will be pre-screened in EPIC for eligibility. They may be approached during a clinical visit, or the research team may call them prior to or after a scheduled visit to introduce the study. Women can be enrolled anytime between the confirmation of pregnancy and 24 weeks/0 days gestation. For convenience, research visits can be conducted at the time of a scheduled clinical visit, or at a separate time.

Inclusion criteria

  • Pregnant women receiving care in University of Pennsylvania Health System
  • Between 16-24 weeks gestation

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
400 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. Preterm Birth

    Time frame: At time of delivery

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Study locations

1 site
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02560246
Lead sponsor
University of Pennsylvania
Collaborators
March of Dimes
Responsible party
Sponsor
First posted
Sep 25, 2015
Start date
May 4, 2015
Primary completion
Aug 29, 2017
Completion
Aug 29, 2017
Last update
May 2, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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