Probiotic Supplementation During Pregnancy in Preeclampsia High-risk Groups

Nanfang Hospital, Southern Medical University

Status: Not yet enrolling

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

Treatments: Dietary Supplement: aspirin 100mg and probiotics 1 bag

Study type: Interventional

Funder types: Other

Identifiers

NCT05554185

NFEC-2022-358

Details and patient eligibility

About

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.

Enrollment: 338 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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338 participants in 2 patient groups, including a placebo group

group A

Experimental group

Description:

aspirin 100mg and probiotics 1 bag

Treatment:

Dietary Supplement: aspirin 100mg and probiotics 1 bag

group B

Placebo Comparator group

Description:

aspirin 100mg and placebo1 bag

Treatment:

Dietary Supplement: aspirin 100mg and probiotics 1 bag