NCT06347770 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
| NCT ID | NCT06347770 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Zhe Li |
| Condition | Microbiota |
| Study Type | INTERVENTIONAL |
| Enrollment | 404 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 404 participants in total. It began in 2024-01-08 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06347770 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Microbiota. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06347770 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06347770 currently recruiting?
Yes, NCT06347770 is actively recruiting participants. Contact the research team at mcal@foxmail.com for enrollment information.
Where is the NCT06347770 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China.
Who is sponsoring the NCT06347770 clinical trial?
NCT06347770 is sponsored by Zhe Li. The trial plans to enroll 404 participants.