The Microbiome in (Non-) Obese Pregnancy and Pregnancy Outcomes

Last updated: September 12, 2024
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Treatment

Blood withdrawal

Clinical Study ID

NCT05754645
NL80155.078.22/OZBS72.21318
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

This research aims to elucidate an underlying mechanism of maternal obesity induced pregnancy and longterm health complications for mothers and their offspring.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participation in Predict study

  • Preconceptional women who wish to become pregnant or pregnancy <13 weeks ofgestational age.

  • BMI > 30 kg/m2 or 18-25 kg/m2

  • Understanding of Dutch in speaking and reading

  • Willingness to give written informed consent

Exclusion

Exclusion Criteria:

  • Age < 18 years and > 45 years.

  • ≥13 weeks of gestational age

  • Multiple pregnancy

  • Smoking

  • Gastro-intestinal diseases, heart diseases, liver, pancreas and kidney diseases.

  • Use of antibiotics < 2 weeks before sampling

  • Pre-existent diabetes mellitus

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: Blood withdrawal
Phase:
Study Start date:
July 21, 2022
Estimated Completion Date:
August 21, 2026

Study Description

With the increasing global prevalence of obesity, pregnancy problems related to maternal obesity are increasingly occurring. Microbial gut symbiosis plays an important role in health, with dysbiosis being associated with diseases such as obesity. Of interest are pregnancy, dietary patterns and pre- or probiotics that affect the composition of the gut microbiome. The microbiome itself can influence many physiological processes, such as immune responses (production of microbial products) and the nutrient-dependent one-carbon metabolism. It is hypothesized that gut dysbiosis, due to maternal obesity, during pregnancy can be considered an endogenous chronic stressor causing impaired immune response and carbon metabolism. Both processes result in excessive oxidative stress, detrimental to cell replication, differentiation and epigenetic programming of maternal and infant tissues. Together, these biological disturbances contribute to placental and vascular dysfunction, leading to an increased risk of preeclampsia or gestational diabetes mellitus. Vertical (during pregnancy) and horizontal (during delivery) transmission of gut dysbiosis from mother to newborn and epigenetic placental and foetal changes may ultimately lead to macrosomia and obesity in children. Therefore, the differences between the gut and vaginal microbiome, maternal and fetal immune responses and one-carbon metabolism in obese versus normal-weight pregnant women will be analysed.

Connect with a study center

  • Erasmus MC

    Rotterdam, Zuid-Holland 3015GD
    Netherlands

    Active - Recruiting

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