Back to results

Probiotic Supplementation During Pregnancy in Preeclampsia High-risk Groups

Primary Purpose

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

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

aspirin 100mg and probiotics 1 bag

About this trial

This is an interventional prevention trial for PE (Pre-eclampsia) High-risk Population With Gut Microbiota Dysbiosis During Their Pregnancy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

group A

group B

Arm Description

aspirin 100mg and probiotics 1 bag

aspirin 100mg and placebo1 bag

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05554185

First Posted

September 21, 2022

Last Updated

September 21, 2022

Sponsor

Nanfang Hospital, Southern Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05554185

Brief Title

Probiotic Supplementation During Pregnancy in Preeclampsia High-risk Groups

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 21, 2022 (Anticipated)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

338 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group A

Arm Type

Experimental

Arm Description

aspirin 100mg and probiotics 1 bag

Arm Title

group B

Arm Type

Placebo Comparator

Arm Description

aspirin 100mg and placebo1 bag

Intervention Type

Dietary Supplement

Intervention Name(s)

aspirin 100mg and probiotics 1 bag

Intervention Description

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

Primary Outcome Measure Information:

Title

The incidence of preeclampsia

Description

Time Frame

From being recruited to 6 weeks after delivery

Secondary Outcome Measure Information:

Title

The incidence of fetal growth restriction

Description

Time Frame

From being recruited to 6 weeks after delivery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yichi Zhang

Phone

18774562132

1525683944@qq.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31900289

Citation

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.

Results Reference

result

Learn more about this trial

Probiotic Supplementation During Pregnancy in Preeclampsia High-risk Groups

We'll reach out to this number within 24 hrs