Effect of Probiotics Before Cesarean Section on Postoperative Recovery in Pregnant Women

Microbiota Clinical Trial

Official title:

Effect of Probiotics Before Cesarean Section on Postoperative Recovery in Pregnant Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06347770
• Other study ID #: ThirdSunYat-senECII202329903
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Microbiota
• Postoperative Recovery

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