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

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ClinicalTrials.gov Identifier: NCT03663556
Recruitment Status : Unknown
Verified August 2018 by Universidade do Porto.
Recruitment status was:  Recruiting
First Posted : September 10, 2018
Last Update Posted : October 2, 2018
Sponsor:
Collaborators:
Center for Health Technology and Services Research
Maternidade Dr. Alfredo da Costa
NOVA Medical School, Universidade Nova de Lisboa
Information provided by (Responsible Party):
Universidade do Porto

Tracking Information
First Submitted Date July 19, 2018
First Posted Date September 10, 2018
Last Update Posted Date October 2, 2018
Actual Study Start Date May 25, 2017
Estimated Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 28, 2018)
  • Changes from baseline intestinal microbiota composition of preterm infants at 7, 14 and 21 days. [ Time Frame: The first fecal sample (meconium) of preterm infants will be collected. Afterwards, fecal samples will be collected every 7 days, during 21 days. ]
    The intestinal microbiota profile of preterm infants will be evaluated over time.
  • 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. [ Time Frame: Infant-feeding type of preterm infants before the first, second, third and fourth collection will be recorded during these 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.
Original Primary Outcome Measures
 (submitted: September 5, 2018)
  • Changes from baseline intestinal microbiota composition of preterm infants at 7, 14 and 21 days. [ Time Frame: The first fecal sample (meconium) of preterm infants will be collected. Afterwards, fecal samples will be collected every 7 days, during 21 days. ]
    The intestinal microbiota profile of preterm infants will be evaluated over time.
  • Changes from baseline infant-feeding profile at 7,14 and 21 days. [ Time Frame: Infant-feeding type of preterm infants before the first, second, third and fourth collection will be recorded during these 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.
Change History
Current Secondary Outcome Measures
 (submitted: September 28, 2018)
  • Maternal intestinal microbiota composition, analyzed by RT-PCR. [ Time Frame: Maternal fecal samples will be collected after delivery up to 1 week. ]
    Mother's will be asked to collect their own fecal samples for gut microbiota analysis by RT-PCR. An appropriate stool collection kit will be provided (EasySampler Stool Collection kit).
  • Changes in maternal gut microbiota in relation to clinical variables described below [ Time Frame: Clinical variables will be collected daily, until study completion an average of 2 years. ]
    Changes in intestinal microbiota profile of preterm infants' mothers will be evaluated in relation to mode of delivery, mother's gestational age, dietary pattern during pregnancy, weight gain in gestation and antibiotic exposure.
Original Secondary Outcome Measures
 (submitted: September 5, 2018)
  • Maternal intestinal microbiota composition, analyzed by RT-PCR [ Time Frame: After delivery, as soon as possible ]
    Mother's will be asked to collect their own fecal samples, after delivery, for gut microbiota analysis. An appropriate stool collection kit will be provided (EasySampler Stool Collection kit).
  • Changes in maternal gut microbiota in relation to clinical variables described below [ Time Frame: Clinical variables will be collected daily, until study completion an average of 2 years. ]
    Changes in intestinal microbiota profile of preterm infants' mothers will be evaluated in relation to mode of delivery, mother's gestational age, dietary pattern during pregnancy, weight gain in gestation and antibiotic exposure.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Meconium and stool samples
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
Condition Very Preterm Infants
Intervention Other: Infant-feeding
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.
Study Groups/Cohorts Very Preterm Infants
Newborn infants with less than 32 weeks admitted in the NICU.
Intervention: Other: Infant-feeding
Publications * Morais J, Marques C, Teixeira D, Durão C, Faria A, Brito S, Cardoso M, Macedo I, Pereira E, Tomé 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 5, 2018)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2018
Estimated Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 2 Days   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Portugal
Removed Location Countries  
 
Administrative Information
NCT Number NCT03663556
Other Study ID Numbers FEEDMI
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Universidade do Porto
Study Sponsor Universidade do Porto
Collaborators
  • Center for Health Technology and Services Research
  • Maternidade Dr. Alfredo da Costa
  • NOVA Medical School, Universidade Nova de Lisboa
Investigators Not Provided
PRS Account Universidade do Porto
Verification Date August 2018