Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
334 participants
INTERVENTIONAL
2023-10-27
2026-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
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.
Study Groups
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Probiotics
Probiotic powder 1 bag per day, as well as health guidance about diet and exercise. From recruitment until OGTT.
Probiotics
Probiotics powder including: Resistant dextrin, inulin, oligosaccharide, erythritol, Lactobacillus plantarum VB165, Bifidobacterium lactis VB301, Lactobacillus rhamnosus VB255, acerola cherry powder, citric acid
Placebo
Placebo 1 bag per day. Similar health guidance about diet and exercise. From recruitment until OGTT
Placebo
placebo with similar appearance and smell but not containing probiotics
Interventions
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Probiotics
Probiotics powder including: Resistant dextrin, inulin, oligosaccharide, erythritol, Lactobacillus plantarum VB165, Bifidobacterium lactis VB301, Lactobacillus rhamnosus VB255, acerola cherry powder, citric acid
Placebo
placebo with similar appearance and smell but not containing probiotics
Eligibility Criteria
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Inclusion Criteria
1. included between 12-16 gestational weeks
2. 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 (+)
Exclusion Criteria
2. Have a history of allergies to the drug components or similar drugs in this study
3. Having long-term smoking or drinking habits
4. Type 1 or type 2 diabetes patients with definite diagnosis before pregnancy
5. Diseases in other important organs such as heart, liver, and kidney
6. with clear digestive system diseases
7. Multiple pregnancy
8. with mental or cognitive impairments who are unable to complete this study
18 Years
50 Years
FEMALE
No
Sponsors
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Quzhou Maternal and Child Health Care Hospital
UNKNOWN
Women's Hospital School Of Medicine Zhejiang University
OTHER
Responsible Party
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Locations
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Women's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-20230226-R
Identifier Type: -
Identifier Source: org_study_id
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