Clinical trial
Origin of the Neonatal Gut Microbiota and Probiotic Intervention
Name
[2019]no.11EthicsCommittee
Description
This study aim to evaluate the origin of the neonatal gut microbiota in 14th days and Probiotic intervention. Samples were obtained from a total of 30 pregnant individuals and their offspring, divided into control group and porbiotics group, analyzing by 16S rRNA amplicon sequencing of the V4 region to evaluate the composition of them. Multiple linear regression were used to evaluate the origin of neonatal gut microbiota.
Trial arms
Trial start
2018-01-01
Estimated PCD
2021-12-31
Trial end
2021-12-31
Status
Completed
Treatment
Probiotic Blend Oral Tablet
In our study, fourteen 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), Lactobacillus delbrueckii bulgaricus (5 ∗ 105 CFU) and Streptococcus thermophilus (5 ∗ 105 CFU) tablets produced by Neimengu Shuangqi Pharmaceutical Co., Ltd. Pregnant individuals in the probiotic group were administered two tablets twice a day (2 g/d) until natural delivery
Arms:
probiotics group
Size
30
Primary endpoint
16S rRNA amplicon sequencing of the V4 region
12 months
Eligibility criteria
Pregnant inclusive criteria were:
1. Chinese woman who is pregnant with a single fetus;
2. First pregnancy and term delivery.
Newborns' inclusive criteria were:
1. Normal weight (\>2500 g, \<4000 g);
2. Term Infant (\>37 weeks, \<42 weeks).
3. Natural birth.
Pregnancy exclusive criteria were:
1. Gastrointestinal disease or family history;
2. Vaginitis before pregnancy;
3. Antibiotic usage during pregnancy;
4. Hypertension, Diabetes Mellitus, Hyperthyroidism, Hypothyroidism, Autoimmune Disease, or Other Endocrine and Metabolic Disease;
5. Gestational Hypertensive Disease, Gestational Diabetes Mellitus or Other Gestational Disease;
6. Transfusion History, Organ Transplantation History or Immunotherapy History.
Newborn's exclusive criteria were:
1. Abnormal weight (\>4000 g, \<2500 g);
2. With Congenital Diseases;3. Intrapartum Fetal Complication.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2024-02-05
1 organization
1 product
1 indication
Product
Probiotic BlendIndication
Microbiota