Clinical trial NCT03663556: Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development
Official title: Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Very Preterm Infants
Keywords: intestinal microbiota
preterm infants
breast milk
donor human milk
formula
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Center for Health Technology and Services Research
name: Maternidade Dr. Alfredo da Costa
name: Universidade Nova de Lisboa
First posted: 2018-09-10
Enrollment: 60
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Very preterm infants born with less than 32 weeks recruited at the NICU of Maternidade Dr. Alfredo da Costa, Centro Hospitalar de Lisboa Central, Lisbon, Portugal

Brief summary: Preterm infants are especially vulnerable to gut microbiota disruption and dysbiosis since their early gut microbiota is less abundant and diverse. Several factors may influence infants' microbiota such as mother's diet, mode of delivery, antibiotic exposure and type of feeding. The main goal of this observational study is to evaluate the impact of different types of feeding (breast milk, donor human milk and preterm formulas) on the intestinal microbiota of preterm infants hospitalized in the neonatal intensive care unit (NICU) of Maternidade Alfredo da Costa (MAC). Furthermore, the influence of mode of delivery and the mother's diet, among others factors, on vertical microbiota transmission will be evaluated. After delivery, mothers will be asked to collect their own fecal samples and will be invited to complete a semi-quantitative food frequency questionnaire. Stool samples will be collected from premature infants every 7 days. DNA will be extracted from fecal samples and different bacterial genus and species will be analyzed.

Detailed description: Meconium and the additional 3 fecal samples will be collected from preterm infants by the nursing team of MAC Neonatology Unit. Fecal samples will be collected every 7 days, during 21 days, from diapers into sterile tubes. Mothers will be asked to collect their own fecal samples with an appropriate stool collection kit (EasySampler®) and will be invited to complete a semi-quantitative food frequency questionnaire, previously validated for the Portuguese population.

Infant-feeding profile (breast milk, donor human milk or formula) of preterm infants will be recorded every day to select the most representative (\>50 %) type of infant-feeding received during the 7 days prior to each fecal sample collection.

Additionally, detailed clinical data will be collected during the preterm infant enrollment in the study. Personal clinical data includes sociodemographic information and clinical intrapartum and postpartum outcomes, such as newborn's weight, days of antibiotic exposure, number of total days of hospitalization and others outcomes related to the preterm clinical evolution.

Eligibility criteria: Inclusion Criteria:

* To be eligible for enrolment, preterm infants must have been admitted to the NICU in less than 24 hours of life, have been born with less than 32 weeks with absence of malformations or metabolic diseases.

Exclusion Criteria:

* non applicable

Primary outcomes:
measure: Changes from baseline intestinal microbiota composition of preterm infants at 7, 14 and 21 days.
timeFrame: The first fecal sample (meconium) of preterm infants will be collected. Afterwards, fecal samples will be collected every 7 days, during 21 days.
measure: Changes from baseline intestinal microbiota composition of preterm infants in relation to infant-feeding profile (breast milk, donor human milk or formula) at 7,14 and 21 days.
timeFrame: Infant-feeding type of preterm infants before the first, second, third and fourth collection will be recorded during these 21 days.
Secondary outcomes:
measure: Maternal intestinal microbiota composition, analyzed by RT-PCR.
timeFrame: Maternal fecal samples will be collected after delivery up to 1 week.
measure: Changes in maternal gut microbiota in relation to clinical variables described below
timeFrame: Clinical variables will be collected daily, until study completion an average of 2 years.
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Maternidade Dr. Alfredo da Costa, Centro Hospitalar de Lisboa Central
city: Lisbon
country: Portugal
facility: NOVA Medical School, Universidade Nova de Lisboa
Study officials:
References:
citation: Morais J, Marques C, Teixeira D, Durao C, Faria A, Brito S, Cardoso M, Macedo I, Pereira E, Tome T, Calhau C. Extremely preterm neonates have more Lactobacillus in meconium than very preterm neonates - the in utero microbial colonization hypothesis. Gut Microbes. 2020 Nov 9;12(1):1785804. doi: 10.1080/19490976.2020.1785804. Epub 2020 Jul 13.