Probiotic Supplementation During Pregnancy in Preeclampsia High-risk Groups

NCT ID: NCT05554185

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-21
• Study Completion Date: 2024-12-31

Brief Summary

In this randomized controlled study, preventive intervention of aspirin combined with probiotics or aspirin combined with placebo would given to PE (pre-eclampsia) high-risk population with gut microbiota dysbiosis during their pregnancy, and finally assess the efficacy and safety of aspirin combined with probiotics to prevent PE.

Conditions

PE (Pre-eclampsia) High-risk Population With Gut Microbiota Dysbiosis During Their Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

group A

aspirin 100mg and probiotics 1 bag

Group Type: EXPERIMENTAL

aspirin 100mg and probiotics 1 bag

Intervention Type: DIETARY_SUPPLEMENT

taking aspirin 100mg and probiotics 1 bag per day from 14-16 weeks of pregnancy until 35 + 6 weeks of pregnancy or emergency delivery.

group B

aspirin 100mg and placebo1 bag

Group Type: PLACEBO_COMPARATOR

aspirin 100mg and probiotics 1 bag

Intervention Type: DIETARY_SUPPLEMENT

taking aspirin 100mg and probiotics 1 bag per day from 14-16 weeks of pregnancy until 35 + 6 weeks of pregnancy or emergency delivery.

Interventions

aspirin 100mg and probiotics 1 bag

taking aspirin 100mg and probiotics 1 bag per day from 14-16 weeks of pregnancy until 35 + 6 weeks of pregnancy or emergency delivery.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• PE high-risk population aged 18-50 years with gut microbiota dysbiosis
• No severe cardiopulmonary diseases
• No severe hepatic and renal insufficiency
• No severe active infection
• Pregnant women did not take antibiotics or antifungal drugs 30 days before fecal sample collection; No probiotic preparation was taken 2 weeks before sample collection; Never take drugs that may interfere with glucose and lipid metabolism
• No diseases affecting intestinal microecology
• No history of smoking and drinking
• The researchers evaluated those pregnant women expected to deliver more than 20 weeks
• Voluntarily participate in this clinical study and sign the informed consent form

Exclusion Criteria

• With severe cardiopulmonary, hepatic and renal insufficiency
• With uncontrolled active infections 2 weeks before enrollment
• Subjects took antibiotics or antifungal drugs 30 days before sample collection; Take probiotics 2 weeks before sample collection; Have taken drugs that may interfere with glucose and lipid metabolism
• with diseases affecting intestinal microecology
• Smoking and drinking history
• With acute gastrointestinal ulcer
• Hemorrhagic constitution
• Other discomfort assessed by the investigato

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yichi Zhang

Role: CONTACT

1525683944@qq.com

18774562132

References

Chen X, Li P, Liu M, Zheng H, He Y, Chen MX, Tang W, Yue X, Huang Y, Zhuang L, Wang Z, Zhong M, Ke G, Hu H, Feng Y, Chen Y, Yu Y, Zhou H, Huang L. Gut dysbiosis induces the development of pre-eclampsia through bacterial translocation. Gut. 2020 Mar;69(3):513-522. doi: 10.1136/gutjnl-2019-319101. Epub 2020 Jan 3.

Reference Type: RESULT

PMID: 31900289 (View on PubMed)

Other Identifiers

NFEC-2022-358

Identifier Type: -

Identifier Source: org_study_id