Probiotic Supplementation to Improve the GUT Microbiota of Very Low Birth Weight Preterm, a Pilot Study

NCT02192996 | Completed Early Phase 1

• 2 other identifiers: HULP3551Universidad Complutense Madrid
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Other Preterm Infants; NEC

Keywords

VLBW preterm; GUT microbiota; probiotics supplementation; immune compounds

Outcome Measures

Primary Outcomes (1)

• changes in microbiological counts in feces of preterm infants

  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.

  prior to initiate and at 7th, 14th, 21th, 28th days receiving probiotics

Secondary Outcomes (2)

• concentration of immunological parameters on feces

  prior to star and at 7th, 14th and 21st days of receiving probiotics

• concentration of immunological parameters on plasma samples

  7th, 14th, 19th and 24th days of receiving probiotic).

Other Outcomes (1)

• clinical features during NICU stay

  during NICU stay, arround 1 moth

Study Arms (1)

Probiotics supplementation

OTHER

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.

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

blood and fecal samples were collected from five VLBW preterms which were supplemented with a probiotic mixture of Bifidobacterium breve / Lactobacillus salivarius isolated from human milk

Also known as: "Bifidobacterium breve / Lactobacillus salivarius mixture"

Probiotics supplementation

Eligibility Criteria

• Age: 1 Hour - 1 Week
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• preterm infants with birth weight less than one thousand and three hundred grammes
• preterm infants with gestational age less than 29 weeks

You may not qualify if:

• mayor malformations
• chromosomopathies
• congenital infections
• non parental consent

Sponsors & Collaborators

• Hospital Universitario La Paz: lead
• Universidad Complutense de Madrid: collaborator

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Miguel Saenz de Pipaon, PhD. MD.

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: July 17, 2014
• Study Start: December 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: July 1, 2014
• Last Updated: July 17, 2014

Record last verified: 2014-07

Locations

ES (1)