Probiotic Supplementation During Pregnancy in Preeclampsia High-risk Groups

Effects of Probiotic Supplementation During Pregnancy on Maternal and Infant Outcomes in Preeclampsia High-risk Groups Based on Abnormal Intestinal Flora: a Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: PE (Pre-eclampsia) High-risk Population With Gut Microbiota Dysbiosis During Their Pregnancy
• Intervention / Treatment: Dietary supplement: aspirin 100mg and probiotics 1 bag

• Study Type: Interventional
• Enrollment (Anticipated): 338
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yichi Zhang; Phone Number: 18774562132; Email: 1525683944@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; aspirin 100mg and probiotics 1 bag	Dietary supplement: 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.
Placebo Comparator: group B; aspirin 100mg and placebo1 bag	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of preeclampsia	After 20 weeks of pregnancy, systolic blood pressure ≥ 140mmHg and / or diastolic blood pressure ≥ 90mmHg, accompanied by any of the following items: urinary protein ≥ 0.3g/24h, or urinary protein / creatinine ratio ≥ 0.3,or random urinary protein ≥ (+) (examination method for unconditional protein quantification); Non-albuminuria can be accompanied by any kind of organ or system involvement: heart, lung, liver, kidney and other important organs, or abnormal changes in blood system, digestive system, nervous system, placenta-fetus, etc.	From being recruited to 6 weeks after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of fetal growth restriction	due to the influence of pathological factors such as mother, fetus and placenta, fetal growth does not reach its due genetic potential, which is characterized by fetal body weight or abdominal circumference estimated by ultrasound lower than the 10th percentile of the corresponding gestational age	From being recruited to 6 weeks after delivery

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 21, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia; Dysbiosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: NFEC-2022-358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No