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Preterm BirthMGMNCT02560246

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

An observational study of Preterm Birth, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Preterm Birth
How many people
400 participants
Where
1 siteUnited States
Study dates
4 May 2015to 29 Aug 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

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

Who cannot join

  • Multiple gestation
  • Fetal chromosomal abnormality or major fetal anomaly
  • Intrauterine fetal demise
  • Maternal HIV
  • Chronic kidney disease
  • Transplant
Show all 9Show fewer
  • Prior weight loss surgery
  • Vegan diet
  • Chronic use of immunosuppresive medications or steriods

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Conditions
Preterm Birth
Keywords
Microbiome
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02560246
Study groupRoleWhat they receive
Preterm LaborSingleton 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 LaborAdmitted to the hospital with spontaneous labor (regular contractions, cervical dilation) or spontaneous rupture of membranes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preterm Birth

    Measured: At time of delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2015 (estimated)
  2. Study start4 May 2015
  3. Primary completion29 Aug 2017
  4. Study completion29 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02560246
Sponsor's protocol ID
822218
Acronym
MGM
Status last verified
May 2018
First submitted
23 Sep 2015
Last updated
2 May 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Preterm Birth, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preterm Birth (time frame: At time of delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.

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