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.
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
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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted25 Sep 2015 (estimated)
- Study start4 May 2015
- Primary completion29 Aug 2017
- Study completion29 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- March of Dimes
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Gut Microbiome (MGM) Study of Diet, the Gut Microbiome and Preterm Birth
- ClinicalTrials.gov ID
- NCT02560246
- Acronym / sponsor ID
- MGM / 822218
- Conditions
- Preterm Birth
- Keywords
- Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- March of Dimes
- Study start
- 4 May 2015 (actual)
- Primary completion
- 29 Aug 2017 (actual)
- Study completion
- 29 Aug 2017 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Pregnant women receiving care in University of Pennsylvania Health System
- Between 16-24 weeks gestation
Key exclusion criteria (9 listed)
- Multiple gestation
- Fetal chromosomal abnormality or major fetal anomaly
- Intrauterine fetal demise
- Maternal HIV
- Chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preterm Birth
Time frame: At time of delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.