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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06347770
Other study ID # ThirdSunYat-senECII202329903
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date October 2025

Study information

Verified date April 2024
Source Third Affiliated Hospital, Sun Yat-Sen University
Contact Zhe Li
Phone +86-15521327083
Email mcal@foxmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the effect of probiotics 7 days before cesarean section (CS) on postoperative recovery and the change of gut microbiota in pregnant women. Samples were obtained from a total of 80 pregnant individuals, divided into control group and probiotics group. Anal exhaust time and first defecating time were set as the primary outcome of recovery of CS. 16S rRNA amplicon sequencing of the V4 region was analyzed to evaluate the composition of them.


Description:

Study design and participants A total of 80 samples were obtained from pregnant individuals receiving antenatal care at the 3rd Affiliated Hospital of Sun Yat-sen University and the 1st Affiliated Hospital of Jinan University. Informed consent was obtained from pregnant women (at least 32 gestational weeks) who met the inclusion criteria. Pregnant women were followed until 7 days after cesarean section. Pregnant inclusive criteria were: 1. Chinese woman who is pregnant with a single fetus; 2. Pregnant women who planned to perform lower section of uterus due to social factors, relative head basin asymmetry, macrosomia, cicatricial uterus and other reasons. Pregnant exclusive criteria were: 1. Gastrointestinal disease or family history; 2. Antibiotic usage during pregnancy; 3. Habit of eating foods with high probiotic content such as yogurt and cheese during pregnancy; 4. Take other probiotics or probiotic drinks during pregnancy regularly; 5. Hypertension, Diabetes Mellitus, Hyperthyroidism, Hypothyroidism, Autoimmune Disease, or Other Endocrine and Metabolic Disease; 6. Transfusion History, Organ Transplantation History or Immunotherapy; 7. Gestational hypertension, gestational diabetes, gestational thyroid dysfunction and other endocrine and metabolic diseases occurred during this pregnancy. Probiotic management In our study, forty pregnant women were randomly assigned to the probiotic group, and the rest were assigned to the control group. After enrollment, pregnant women in the probiotic group received the living Bifidobacterium longum (5 # 106 CFU) tablets produced by Neimengu Shuangqi Pharmaceutical Co., Ltd. Pregnant individuals in the probiotic group were administered four tablets three times a day (2 g/d) for seven days before surgery until the fourth day after surgery, and those in the control group took no pills. Fecal, venous blood and data collection Fecal collection Feces from pregnant women were collected twice-the last time before surgery and the first time after surgery. Feces collected were both collected internally, thereby avoiding contamination with foreign material. The feces were transferred to the laboratory freezer at 80ºC within 30 min of collection when obtained in the hospital. Feces collected were stored in a domestic refrigerator and transferred to the laboratory freezer for 24 hours when obtained outside the hospital. Venous blood collection Venous blood from pregnant women was collected twice-before and after surgery. The venous blood was obtained in the hospital and centrifuged within 30 minutes in a temperature-controlled centrifuge at 3000 r/min at 4℃ for 10 minutes after 2ml of which was collected, then the serum samples were transferred to the laboratory freezer at -80ºC. Data collection Data from pregnant women was collected before and after surgery, including age, height, pre-delivery weight, time of first anal exhaust and defecation.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date October 2025
Est. primary completion date October 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Chinese woman who is pregnant with a single fetus - Pregnant women who planned to perform lower section of uterus due to social factors, relative head basin asymmetry, macrosomia, cicatricial uterus and other reasons. Exclusion Criteria: - Gastrointestinal disease or family history - Antibiotic usage during pregnancy - Habit of eating foods with high probiotic content such as yogurt and cheese during pregnancy - Take other probiotics or probiotic drinks during pregnancy regularly - Hypertension, Diabetes Mellitus, Hyperthyroidism, Hypothyroidism, Autoimmune Disease, or Other Endocrine and Metabolic Disease - Transfusion History, Organ Transplantation History or Immunotherapy - Gestational hypertension, gestational diabetes, gestational thyroid dysfunction and other endocrine and metabolic diseases occurred during this pregnancy.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Probiotic Blend Oral Tablet
In our study, forty pregnant women were randomly assigned to the probiotic group, and the rest were assigned to the control group. After enrollment, pregnant women in the probiotic group received a combination of living Bifidobacterium longum (5 #106 CFU) by Neimengu Shuangqi Pharmaceutical Co., Ltd. Pregnant individuals in the probiotic group were administered four tablets three times a day (2 g/d) for seven days before surgery until the fourth day after surgery.

Locations

Country Name City State
China Zhe Li Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary analysis of postoperative recovery The specific time between the first postoperative exhaust, defecation and the completion of the operation as well as the outcome of blood routine examination were collected. Difference analysis of each group was performed. All the measurement data are presented as the mean ± standard error. Assessments of Operational Taxonomic Units differences in the probiotic group and control group were performed using independent sample t tests, and P < 0.05 was considered to indicate statistical significance. Other outcomes were analyzed using multiple linear regression. All data were analyzed using SPSS 23.0 statistical software (SPSS, Inc., Chicago, IL, USA). 12 months
Primary 16S rRNA amplicon sequencing of the V4 region Difference analysis of each group was performed. All the measurement data are presented as the mean ± standard error. Assessments of Operational Taxonomic Units differences in the probiotic group and control group were performed using independent sample t tests, and P < 0.05 was considered to indicate statistical significance. Other outcomes were analyzed using multiple linear regression. All data were analyzed using SPSS 23.0 statistical software (SPSS, Inc., Chicago, IL, USA). 12 months
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