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Effects of Oligosaccharide-Sialic Acid (OS) Compound on Maternal-Newborn Gut Microbiome, Glucose Metabolism and Systematic Immunity in Pregnancy: Protocol for a Randomized Controlled Study

Efficacy evaluation of compound oligosaccharide-sialic acid administration during pregnancy on maternal-infant gut microbiota modification

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017192
Enrollment
Unknown
Registered
2018-07-17
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus

Interventions

experimental group:Oligosaccharide-sialic acid compound
Control group:Placebo

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: For pregnancies 1. 18 to 40 years of age, residents from Beijing; 2. First prenatal care visit during 5~8 gestational weeks; 3. Accessibility and voluntary provision of informed consent. For newborns: 1. With no complications during pregnancy and at delivery; 2. Full-term with birthweight 2500g to 4000g; 3. No genetic or morphological abnormalities; 4. Exclusively breastfed

Exclusion criteria

Exclusion criteria: 1. a smoker, an alcohol abuser, or a drug user; 2. Complicated with chronic diseases, e.g. diabetes, chronic hypertension, etc. or taking any prescribed chronic medications, including steroids.

Design outcomes

Primary

MeasureTime frame
Microbiome profile;Incidence of GDM;—

Secondary

MeasureTime frame
glycolipid metabolism parameters;Immunologic parameters;weight gain;Other complications;growth and development of offspring;—

Countries

China

Contacts

Public ContactMa Jingmei

Peking University First Hospital

jingmeima@bjmu.edu.cn+86 13520677420

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026