Preventive Effect of Probiotics in GDM

NCT06938464 | Recruiting DMC

• 1 other identifier: IRB-20230226-R
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

Brief Summary

Gut microbiota is instrumental in the microbial and metabolic network of pregnant women, and is potentially related with gestational diabetes. Perinatal probiotic intervention contributes to improved glucose regulation during pregnancy. Our randomized, double-centered, placebo-controlled study is planned to recruit 334 pregnant women who is in high risk for gestational diabetes. They will be assumed randomly probiotic powder per day or placebo from 12-16th gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks. Perinatal outcomes about neonatal weight will be registered.

Conditions

Gestational Diabetes Mellitus (GDM)

Outcome Measures

Primary Outcomes (1)

• the incidence of gestational diabetes

  The number of cases and incidence of gestational diabetes according to OGTT

  24-28th weeks gestation

Secondary Outcomes (2)

• The incidence of macrosomia

  Delivery

• Weight gain during pregnancy (kg)

  Delivery

Study Arms (2)

Probiotics

ACTIVE COMPARATOR

Probiotic powder 1 bag per day, as well as health guidance about diet and exercise. From recruitment until OGTT.

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

Placebo 1 bag per day. Similar health guidance about diet and exercise. From recruitment until OGTT

Dietary Supplement: Placebo

Interventions

Probiotics DIETARY_SUPPLEMENT

Probiotics powder including: Resistant dextrin, inulin, oligosaccharide, erythritol, Lactobacillus plantarum VB165, Bifidobacterium lactis VB301, Lactobacillus rhamnosus VB255, acerola cherry powder, citric acid

Probiotics

Placebo DIETARY_SUPPLEMENT

placebo with similar appearance and smell but not containing probiotics

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women who meet the high-risk indicators for GDM and agree to participate in this study.
• included between 12-16 gestational weeks
• A woman was considered high risk when her pre-pregnancy BMI ≥ 24 kg/m\^2, having family history of diabetes (type 1 or 2), GDM or PCOS (polycystic ovary syndrome) history, history of delivering macrosomia or stillbirth, or glucose in urine (+)

You may not qualify if:

• Taking probiotics or prebiotics within the past month
• Have a history of allergies to the drug components or similar drugs in this study
• Having long-term smoking or drinking habits
• Type 1 or type 2 diabetes patients with definite diagnosis before pregnancy
• Diseases in other important organs such as heart, liver, and kidney
• with clear digestive system diseases
• Multiple pregnancy
• with mental or cognitive impairments who are unable to complete this study

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead
• Quzhou Maternal and Child Health Care Hospital: collaborator

Study Sites (1)

Women's Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Danqing Chen, Prof

CONTACT

86571-87061501; Chendq@zju.edu.cn

Xinning Chen

CONTACT

+8618817362544; jhviolet@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The random number table is compiled by the investigator who is specially responsible for grouping and saved. The investigator packaged and coded drugs according to random number table, and recorded. The packaged and numbered drugs are stored in the enrollment office. When the participants meet the inclusion criteria by care providers (doctors), the enrollment office generates a random number for each subject. The participants received the package of drugs according to their random number, and the random number was recorded in the record book. If there are adverse events or the subjects request to withdraw from the trial, the investigator should uncover the blind.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: October 27, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

CN (1)