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

NCT06347770 | Recruiting Phase 1

• 1 other identifier: ThirdSunYat-senECII202329903
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Microbiota; Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• exhaust time

  DAY 4

Study Arms (2)

probiotics group

EXPERIMENTAL

pregnancies in probiotics group need probiotics management

Drug: Probiotic Blend Oral Tablet

Placebo

PLACEBO COMPARATOR

Drug: Placebo Oral Tablet

Interventions

Placebo Oral Tablet DRUG

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.

Placebo

Probiotic Blend Oral Tablet DRUG

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.

probiotics group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhe Li: lead

Study Sites (2)

The first affiliated hospital of Jinan University

Guangzhou, Guangdong, 510000, China

RECRUITING

The third affiliated hospital of Sun Yat sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Central Study Contacts

Zhe Li

CONTACT

+86-15521327083; mcal@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: January 8, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-03

Locations

CN (2)