Clinical Trials Logo

Clinical Trial 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 80 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. 16S rRNA amplicon sequencing of the V4 region was analyzed to evaluate the composition of them.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06347770
Study type Interventional
Source Third Affiliated Hospital, Sun Yat-Sen University
Contact Zhe Li
Phone +86-15521327083
Email mcal@foxmail.com
Status Recruiting
Phase N/A
Start date November 1, 2023
Completion date October 2025

See also
  Status Clinical Trial Phase
Withdrawn NCT03239197 - Project SHARE (motherS Have All the Right microbEs) N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Recruiting NCT06144905 - Norwegian Microbiota Study in Anorexia Nervosa
Completed NCT05864352 - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Recruiting NCT04138979 - Intestinal Microbiota of Breast Cancer Patients Undergoing Chemotherapy
Recruiting NCT04132713 - Study on Skin Microbiome of HFS
Completed NCT05726435 - Effects of Soluble Dietary Fiber on Sport Efficiency and Fatigue Delay in Top Basketball Players N/A
Recruiting NCT02695784 - Probiotics After Discharge Phase 4
Completed NCT03543891 - Intestinal Microbiota and Thyroid Cancer
Completed NCT05242913 - Effects of Resistant Potato Starch on the Gut Microbiota N/A
Recruiting NCT04200521 - The Effect of Bariatric Procedures on Gut Microbiota in Obese Individuals in United Arab Emirates and Lebanon
Recruiting NCT05891977 - Effect of Tomato Paste Consumption on the Microbiota-gut-brain Axis in Healthy Adults N/A
Completed NCT02988349 - Ecological Effect of Arginine Dentifrice on Oral Microbiota N/A
Completed NCT05352724 - Clinical Trial to Evaluate the Efficacy of a Sport Drink After High-intensity Aerobic Exercise N/A
Completed NCT04674839 - The Impact of MS-20 on Gut Microbiota Composition in Adult Individuals N/A
Completed NCT03754504 - Effects of Cranberry Powder Supplements on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT05394948 - Circular Economy and the Design of Healthy and Sustainable Food and Ingredients N/A
Terminated NCT03752372 - Microbiome Alterations in IL10RA-deficient Patients After HSCT
Completed NCT05974124 - Effectiveness of Ophthalmic Antiseptic Preparations N/A
Recruiting NCT02005003 - Cognitive and Metabolic Effects of a Probiotic Supplement N/A