Origin of the Neonatal Gut Microbiota and Probiotic Intervention
Condition: Microbiota
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      Study design and participants A total of 30 samples were obtained from pregnant individuals
      receiving antenatal care at the 1st Affiliated Hospital of Jinan University. Informed consent
      was obtained from pregnant women (at least 32 gestational weeks) who met the inclusion
      criteria. Newborns were followed until 14 days after natural delivery. 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. Pregnanct 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.

      Probiotic management 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, and those in the control group took no pills.

      Fecal, vaginal secretion, placental, and meconium collection Fecal collection Feces from
      pregnant patients were collected twice-between weeks 32 and 34 and before natural labor.
      Feces collected at weeks 32-34 were collected internally, thereby avoiding contamination with
      foreign material. The feces were stored in a domestic refrigerator and transferred to the
      laboratory freezer at -80 ºC for 24 hours. Feces collected before labor were obtained in the
      hospital and transferred to the laboratory freezer within 30 min of collection.

      Vaginal secretion collection Vaginal secretions were collected twice between weeks 32 and 34
      and before natural labor. The pregnant woman was asked to not engage in sexual behavior,
      clean the vulva, clean the vagina, or use vaginal medicine within 48 hours before sample
      collection. Vaginal secretions before natural labor were collected before membrane rupture
      occurred. The samples were transferred to the laboratory freezer within 30 min of collection,
      thereby avoiding contamination by foreign material.

      Placenta collection Placenta samples ranging from the entire umbilical cord to 3 cm were
      collected by stripping the amniotic membrane after natural birth. The blood was rinsed with
      sterile saline. Four to six pieces of placenta were sampled from the fetal surface. Each
      piece had a volume of approximately 1 cm3. The placenta sample was transferred to the
      laboratory freezer within 30 min of collection.

      Meconium collection Meconium was collected three times on the 1st day, the 3rd day, and the
      14th day after natural delivery On the 1st day and 3rd day, meconium was collected
      internally, thereby avoiding contamination with foreign material in the hospital, and was
      transferred to the laboratory freezer within 30 min of collection. On the 14th day, meconium
      was collected, stored in a domestic refrigerator, and then transferred to a laboratory
      freezer within 24 hours of collection.
    

Intervention name(s): Probiotic Blend Oral Tablet
Intervention type(s): Drug
Intervention description(s): 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
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research