The Effect of Oral Gan Shuangbi During the Perinatal Period on the Recovery of Intestinal Function After Cesarean Section in Pregnant Women- A Multicenter, Double-blind, Randomized Controlled Clinical Trial

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 202 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.

Study Overview

• Status: Recruiting
• Conditions: Microbiota; Postoperative Recovery
• Intervention / Treatment: Drug: Probiotic Blend Oral Tablet; Drug: Placebo Oral Tablet

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 404
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhe Li; Phone Number: +86-15521327083; Email: mcal@foxmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • The First Affiliated Hospital of Jinan University
      • Contact: Xiaomei Tang, MD; Phone Number: +86-18028656330; Email: 406606608@qq.com
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • The third affiliated hospital of Sun Yat sen University
      • Contact: Yiwen Zhang, MD; Phone Number: +86-18928780735; Email: zywzssy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Oral Tablet; In our study, 404 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.
Experimental: probiotics group; pregnancies in probiotics group need probiotics management	Drug: Probiotic Blend Oral Tablet; In our study, 404 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
exhaust time	DAY 4

Collaborators and Investigators

• Sponsor: Zhe Li

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ThirdSunYat-senECII202329903

Drug and device information, study documents

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