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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
Very Preterm Infants Other: Infant-feeding

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development
Actual Study Start Date : May 25, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Group/Cohort Intervention/treatment
Very Preterm Infants
Newborn infants with less than 32 weeks admitted in the NICU.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.


Biospecimen Retention:   Samples With DNA
Meconium and stool samples


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663556


Contacts
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Contact: Sara Brito, MD +351 964278547 sarabri@gmail.com
Contact: Conceição Calhau, PhD +351 218 803 000 ccalhau@nms.unl.pt

Locations
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Portugal
Maternidade Dr. Alfredo da Costa, Centro Hospitalar de Lisboa Central Recruiting
Lisbon, Portugal, 1050-010
Contact: Sara Brito, MD    +351 964 278 547    sarabri@gmail.com;   
Contact: Juliana Morais, BsC    +351 362711106    ju_morais17@hotmail.com   
Principal Investigator: Sara Brito, MD         
Sub-Investigator: Manuela Cardoso, BsC         
Sub-Investigator: Teresa Tomé, MD         
Sub-Investigator: Israel Macedo, MD         
NOVA Medical School, Universidade Nova de Lisboa Active, not recruiting
Lisbon, Portugal, 1169-056
Sponsors and Collaborators
Universidade do Porto
Center for Health Technology and Services Research
Maternidade Dr. Alfredo da Costa
NOVA Medical School, Universidade Nova de Lisboa
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT03663556    
Other Study ID Numbers: FEEDMI
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidade do Porto:
intestinal microbiota
preterm infants
breast milk
donor human milk
formula
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications