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NCT Number: NCT02192996

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

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).

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Key information

Conditions

Other Preterm Infants NEC

Age range

1 hour–1 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Hospital Universitario La Paz

Madrid, 28046, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: "Bifidobacterium breve / Lactobacillus salivarius mixture"

Primary outcomes

  1. 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

  1. concentration of immunological parameters on feces

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

    multiplex methodology and enzyme-Linked ImmunoSorbent Assay (ELISA) were used to determine a wide range of immune compounds and calprotectin as immune system status biomarkers: immunoglobulin(Ig) G1, IgG2, IgG3, IgG4, IgM, IgA, interleukin (IL)-1b, IL-6, IL-12,interferon-gamma, Tumor necrosis factor-alpha,IL-2,IL-4,IL-10, IL-13, IL-17, IL-8, growth related oncogene- alpha, macrophages chemoattractant protein-1, macrophage inflammatory protein-1b, IL-5, IL-7, granulocytemacrophage -colony stimulating factor (GM-CSF), granulocyte-colony stimulating factor (G-CSF).

  2. concentration of immunological parameters on plasma samples

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

    multiplex methodology and enzyme-Linked ImmunoSorbent Assay (ELISA) were used to determine a wide range of immune compounds and calprotectin as immune system status biomarkers: immunoglobulin(Ig) G1, IgG2, IgG3, IgG4, IgM, IgA, interleukin (IL)-1b, IL-6, IL-12,interferon-gamma, Tumor necrosis factor-alpha,IL-2,IL-4,IL-10, IL-13, IL-17, IL-8, growth related oncogene- alpha, macrophages chemoattractant protein-1, macrophage inflammatory protein-1b, IL-5, IL-7, granulocytemacrophage -colony stimulating factor (GM-CSF), granulocyte-colony stimulating factor (G-CSF).

Other outcomes

  1. clinical features during NICU stay

    Time frame: during NICU stay, arround 1 moth

    medical staff registered all the clinical status of the enrolled infants, after that the most relevant morbidity parameters associated to prematurity were factorized and evaluated by the clinicians, prior to evaluate the possible relationships with the other outcomes measured.

    -Necrotizing enterocolitis, late onset sepsis, intestinal motility evaluated by feeding tolerance and determination ot total gastrointestinal transit time by the administration of carmin red, type of feeding, respiratory support, intraventricular hemorrhage. Describe healthy status of each preterm

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Collaborators

  • Universidad Complutense de Madrid

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jul 17, 2014
Registry last updated
Jul 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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