Probiotic Supplementation to Improve the GUT Microbiota of Very Low Birth Weight, a Pilot Study
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- changes in microbiological counts in feces of preterm infants
Study Overview
Brief Summary
This pilot trial is designed to investigate the benefits of the use of probiotics in GUT microbiota development and/or immunological biomarkers and how this can be related with the clinical status of very low birth weight preterms during their first weeks of life at the neonatal intensive care unit(NICU).
Detailed Description
This pilot trial is designed to investigate the benefits of the use of mixtures of probiotics isolated from human milk in GUT microbiota development and/or immunological biomarkers. Furthermore, the relationship between evaluated parameters and the clinical status of very low birth weight preterms during their first weeks of life at the NICU will be analysed.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 1 Hour to 1 Week (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •preterm infants with birth weight less than one thousand and three hundred grammes
- •preterm infants with gestational age less than 29 weeks
Exclusion Criteria
- •mayor malformations
- •chromosomopathies
- •congenital infections
- •non parental consent
Arms & Interventions
Probiotics supplementation
Five very low birth weight (VLBW) infants enrolled within 2 days of birth, with a weight < 1300 g and gestational age < 29 weeks and without any malformation or metabolic disease at birth were supplemented with two daily doses of a mixture of "Bifidobacterium breve" and "Lactobacillus salivarius" , probiotic strains isolated from human milk during their first weeks of life. The lyophilized powder has contained at least 1x10^9 colony forming units (CFU) per doses of each one of the probiotic bacteria.
Intervention: Probiotic (Dietary Supplement)
Outcomes
Primary Outcomes
changes in microbiological counts in feces of preterm infants
Time Frame: prior to initiate and at 7th, 14th, 21th, 28th days receiving probiotics
Adequate dilutions of meconium and stool samples were spread onto general and selective culture media for the enumeration of different bacterial species. Identification of isolates was carried out by matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry.
Secondary Outcomes
- concentration of immunological parameters on plasma samples(7th, 14th, 19th and 24th days of receiving probiotic).)
- concentration of immunological parameters on feces(prior to star and at 7th, 14th and 21st days of receiving probiotics)
Investigators
Esperanza Escribano
Medical doctor
Hospital Universitario La Paz