Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development
FEEDMI
1 other identifier
observational
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2017
CompletedFirst Submitted
Initial submission to the registry
July 19, 2018
CompletedFirst Posted
Study publicly available on registry
September 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedOctober 2, 2018
August 1, 2018
1.6 years
July 19, 2018
September 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes from baseline intestinal microbiota composition of preterm infants at 7, 14 and 21 days.
The intestinal microbiota profile of preterm infants will be evaluated over time.
The first fecal sample (meconium) of preterm infants will be collected. Afterwards, fecal samples will be collected every 7 days, during 21 days.
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.
Infant-feeding profile (breast milk, donor human milk or formula) will be recorded every day to select the most representative type of infant-feeding (\> 50 %) received during the 7 days prior to each fecal sample collection.
Infant-feeding type of preterm infants before the first, second, third and fourth collection will be recorded during these 21 days.
Secondary Outcomes (2)
Maternal intestinal microbiota composition, analyzed by RT-PCR.
Maternal fecal samples will be collected after delivery up to 1 week.
Changes in maternal gut microbiota in relation to clinical variables described below
Clinical variables will be collected daily, until study completion an average of 2 years.
Study Arms (1)
Very Preterm Infants
Newborn infants with less than 32 weeks admitted in the NICU.
Interventions
Preterm infants hospitalized in the NICU can be feed by three different types of infant feeding, such as breast milk, donor human milk and/or formulas.
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- non applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidade do Portolead
- Center for Health Technology and Services Researchcollaborator
- Maternidade Dr. Alfredo da Costacollaborator
- Universidade Nova de Lisboacollaborator
Study Sites (2)
Maternidade Dr. Alfredo da Costa, Centro Hospitalar de Lisboa Central
Lisbon, 1050-010, Portugal
NOVA Medical School, Universidade Nova de Lisboa
Lisbon, 1169-056, Portugal
Related Publications (1)
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.
PMID: 32658601DERIVED
Biospecimen
Meconium and stool samples
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2018
First Posted
September 10, 2018
Study Start
May 25, 2017
Primary Completion
December 30, 2018
Study Completion
December 30, 2018
Last Updated
October 2, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share