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RecruitingNCT06347770Updated Apr 15, 2026

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

A Phase 1 interventional study of Probiotic Blend Oral Tablet and Placebo Oral Tablet in Microbiota and Postoperative Recovery, sponsored by Zhe Li. Recruiting at 2 sites in China. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by Zhe Li · Phase 1, Interventional, and Health services research

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
404
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Microbiota
  • Postoperative Recovery
03

In context

Lead sponsor

This is the only study on the registry with Zhe Li as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
404 participants (estimated)

Study arms

  • Experimental
    probiotics group

    pregnancies in probiotics group need probiotics management

    Drug: Probiotic Blend Oral Tablet

  • Placebo comparator
    Placebo

    Drug: Placebo Oral Tablet

Interventions

  • DrugProbiotic 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.

  • DrugPlacebo 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.

06

What researchers measure

Primary outcomes

  1. exhaust time

    Time frame: DAY 4

07

Study locations

2 of 2 sites recruiting
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06347770
Lead sponsor
Zhe Li
Responsible party
Zhe Li (Principal Investigator, Third Affiliated Hospital, Sun Yat-Sen University) — Sponsor-investigator
First posted
Apr 4, 2024
Start date
Jan 8, 2024
Primary completion
Mar 31, 2028 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Apr 15, 2026

Study contacts

Zhe Li
Contact
mcal@foxmail.com
+86-15521327083

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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