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.

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Key information

Conditions

Microbiota Postoperative Recovery

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

The first affiliated hospital of Jinan University, Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

exhaust time

Time frame: DAY 4

Study contacts

Contact information is provided by the study sponsor or research team.

Zhe Li

CONTACT

[email protected]

+86-15521327083

Sponsors and collaborators

Lead sponsor

Zhe Li

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2028
First posted: Apr 4, 2024
Registry last updated: Apr 15, 2026

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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