ISRCTN11690200进行中（未招募）未知
PROMESA: Promotion of a healthy gut microbiome in elective caesarean section arrivals. Can exclusive breastfeeding supplemented with a probiotic promote a sustained healthy gut microbiota in babies born by caesarean section?
Evolve BioSystems, Inc.0 个研究点目标入组 105 人开始时间: 2018年4月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 17/12/2020:
- •1. Singleton pregnancies (primip or multi)
- •2. Pregnant women age 18 and above
- •3. Elective Caesarean section =37 weeks gestation
- •4. Maternal pre-pregnancy BMI < 35kg/m²
- •5. Intention to exclusively breastfeed for at least 35 days, preferably for 6 months
- •6. Non-smoker (gave up prior to pregnancy)
- •7. Intention to exclusively breastfeed for at least 3 months
- •8. Non-smoker (never smoked or gave up prior to enrolment)
- •Previous inclusion criteria:
- •1. Singleton pregnancies (primip or multi)
- •2. Pregnant women age 18 and above
- •3. Elective Caesarean section =37 weeks gestation
- •4. Maternal pre-pregnancy BMI < 35kg/m²
- •5. Resident in UK for 3 years or more
- •6. Intention to exclusively breastfeed for at least 35 days, preferably for 6 months
- •7. Non-smoker (gave up prior to pregnancy)
- •Added 15/07/2020:
- •8. Willingness to vaccinate infant with BCG vaccine no later than Day 4
- •9. Intention to exclusively breastfeed for at least 3 months
- •10. Non-smoker (never smoked or gave up prior to enrolment)
排除标准
- •Current exclusion criteria as of 17/12/2020:
- •At antenatal screening
- •1. Multiple pregnancy
- •2. Vaginal deliveries
- •3. Fetus has a known medical condition that would preclude breastfeeding or alter gut microbiota
- •4. Maternal breast surgery or injury within the past 5 years that would reduce the likelihood of successful exclusive breastfeeding (not exclusionary if mother can evidence successful breastfeeding of a previous infant after the surgery or injury)
- •5. Plan to administer non-study probiotics to infant any time throughout the study
- •6. Plan to apply maternal vaginal swab to infant’s mouth
- •7. Maternal infection with HIV or Hepatitis C or experiencing symptoms of COVID-19
- •8. Maternal smoking (current)
- •9. Maternal medication use that may alter infant’s gut microbiotia (e.g. daily antibiotics)
- •At Day 7 postnatal screen, pre-randomization:
- •1. Infants who have taken antibiotics for more than 3 days
- •2. Intake of formula within 24 hours of the Postnatal Eligibility Screen
- •3. Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection
- •4. Mothers who experienced medical complications that would preclude them from breastfeeding
- •5. Infants who had exposure to maternal vaginal microbiome via oral swab
- •6. Infants who have received the BCG vaccine
- •7. Infants whose caregivers intend to vaccinate their infant with the BCG vaccine prior to 3 months of life
- •8. Infants with known exposure to an individual testing positive for, or experiencing symptoms of, COVID-19
- •Previous exclusion criteria:
- •At antenatal screening
- •1. Multiple pregnancy
- •2. Recent arrival in UK (< 3 years)
- •3. Vaginal deliveries
- •4. Mothers with another child < 14 months of age at recruitment
- •5. Fetus has a known medical condition that would preclude breastfeeding or alter gut microbiota
- •6. Maternal breast surgery or injury within the past 5 years that would reduce the likelihood of successful exclusive breastfeeding (not exclusionary if mother can evidence successful breastfeeding of a previous infant after the surgery or injury)
- •7. Plan to administer non-study probiotics to infant any time throughout the study
- •8. Plan to apply maternal vaginal swab to infant’s mouth
- •9. Maternal infection with HIV or Hepatitis C
- •10. Maternal type 1 or type 2 diabetes (gestational diabetes is not exclusionary)
- •11. Maternal pre-eclampsia
- •12. Smoking this pregnancy
- •13. Plan to leave UK in < 6 months (added 01/08/2019)
- •14. Maternal medication use that may alter infant’s gut microbiotia (e.g. daily antibiotics) (added 01/08/2019)
- •At Day 7 postnatal screen, pre-randomization:
- •1. Infants who have taken antibiotics for more than 3 days
- •2. Intake of formula within 24 hours of the Day 7-9 visit
- •3. Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection
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