Preterm Birth Clinical Trial
Official title:
Maternal Gut Microbiome (MGM) Study of Diet, the Gut Microbiome and Preterm Birth
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
Not yet recruiting |
NCT03418311 -
Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome
|
N/A | |
Not yet recruiting |
NCT03418012 -
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
|
N/A | |
Completed |
NCT02993744 -
Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone
|
N/A | |
Active, not recruiting |
NCT02673216 -
Infection and Adverse Pregnancy Outcome
|
||
Completed |
NCT01683565 -
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
|
Phase 4 | |
Completed |
NCT01412931 -
Protein and Ultrasound Indicators of Preterm Birth
|
N/A | |
Completed |
NCT01460576 -
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
|
N/A | |
Completed |
NCT02606058 -
The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?
|
N/A | |
Terminated |
NCT03715530 -
Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women
|
N/A | |
Completed |
NCT00422526 -
Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial
|
Phase 3 | |
Enrolling by invitation |
NCT04251260 -
Effectiveness of Positioning in Preterm Neonates
|
N/A | |
Completed |
NCT03668860 -
India Dexamethasone and Betamethasone
|
Phase 1 | |
Recruiting |
NCT03638037 -
Correlation Between Maternal Vitamin D Level And Preterm Birth
|
||
Completed |
NCT02225353 -
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
|
Phase 2 | |
Recruiting |
NCT03992534 -
The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth
|
Phase 1 | |
Completed |
NCT03144141 -
Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
|
N/A | |
Completed |
NCT05210985 -
Examination of the Relationship Between Home Affordances With Development
|
||
Completed |
NCT04811742 -
Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn
|
N/A |