Introduction The gut microbiota participates in multiple human biological processes, including metabolism and immune responses. During pregnancy, the dynamics of gut microbiota is involved in physiological adaptation. The disturbed profile of microbiome is associated with maternal complications, such as gestational diabetes mellitus (GDM), which further transfers to the offspring and influence their metabolic and immunological functions in the long term. Prebiotics targeting the gut microbiota and modulating metabolic and immune functions have been shown to be effective in non-pregnant populations with metabolic syndrome. Hence, we propose the use of a prebiotic supplement, oligosaccharide-sialic acid (OS) from the first trimester until delivery in pregnant women, can benefit maternal/new-born gut microbiome, glucose metabolism and innate immunity.
Methods and analysis In this prospective double-blinded randomised clinical trial, recruited singleton pregnancies will be stratified by body mass index (BMI) and randomly assigned to consume the OS preparation or placebo daily from the first trimester. At seven later time points (before and after recruitment in the first trimester, in the middle and third trimesters, before delivery, at birth and 42 days postpartum), compliance will be evaluated and/or biological samples will be collected. Along with maternal clinical information, questionnaires on lifestyle and infant development will be recorded. The primary outcomes are the effect of OS on the maternal-offspring gut microbiome and GDM incidence. The secondary outcomes are maternal glycolipid biochemical parameters, cytokine profiles, weight gain during pregnancy and infant morbidities, growth and development. The study aims to validate the effects of OS on reducing maternal morbidity within different BMI groups. The multiple dimensional dataset generated from the study includes clinical and lifestyle-related information, various biological markers and associated protective or risk factors for morbidity and prognosis. An extended follow-up through 42 days after birth could further explore the intrauterine influence on the long-term health of offspring.
Ethics and dissemination This protocol has been approved by Peking University First Hospital, National Unit of Clinical Trial Ethics Committee (reference number: 164). The results are expected to be published in scientific manuscripts by 2021.
Trial registration number ChiCTR1800017192.
- gut microbiome
- sialic acid
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SW and RP are joint first authors.
SW and RP contributed equally.
Collaborators Professor Lin An from School of Public Health, Peking University.
Contributors SW, RP, YL, SQ, HY and JM conceived the study design. SW and RP drafted and revised the manuscript. HY and JM helped in developing the protocol and will supervise the overall study conduct. All authors provided critical input to the manuscript.
Funding This work was supported by the Beijing Natural Science Foundation (S170002) and the National Key Technologies R&D programme of China (2016YFC1000303). This study was designed independently and will be conducted and interpreted by our research team without interference from any other entity.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The experiment was approved and supervised by PUFH, National Unit of Clinical Trial Ethics Committee. We will report to ethics committee if any adverse outcomes occur and will submit safety reports twice a year. In addition, protocol amendments will be reported and communicated with journal editors and corresponding revisions will be made in clinical trial registration.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request.
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