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NCT03663556: FEEDMI

Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development

Status unknown Last updated 2 October 2018
What this trial tests

trial testing Infant-feeding in Very Preterm Infants in 60 participants. Status unknown.

Timeline
25 May 2017
Primary endpoint
30 December 2018
30 December 2018

Quick facts

Lead sponsorUniversidade do Porto
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment60
Start date25 May 2017
Primary completion30 December 2018
Estimated completion30 December 2018
Sites2 locations across Portugal

Drugs / interventions tested

Conditions studied

Sponsor

Universidade do Porto — full company profile →

Who can join

Under 2 Days, any sex, with Very Preterm Infants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Extremely preterm neonates have more <i>Lactobacillus</i> in meconium than very preterm neonates - the <i>in utero</i> microbial colonization hypothesis.
    Morais J, Marques C, Teixeira D, Durão C, et al · · 2020 · cited 15× · PMID 32658601 · DOI 10.1080/19490976.2020.1785804
  2. Influence of Human Milk on Very Preterms' Gut Microbiota and Alkaline Phosphatase Activity.
    Morais J, Marques C, Faria A, Teixeira D, et al · · 2021 · cited 14× · PMID 34066473 · DOI 10.3390/nu13051564

Verify or expand the search:

Other recruiting trials for Very Preterm Infants

Currently open trials in the same condition.

Other Universidade do Porto trials

Trials by the same sponsor.

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Data sources for this page

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