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

Other Preterm Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192996
• Other study ID #: HULP3551
• Secondary ID: Universidad Comp
• Status: Completed
• Phase: Phase 0
• First received: June 24, 2014
• Last updated: July 16, 2014
• Start date: December 2012
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Week

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Birth Weight
• NEC
• Other Preterm Infants
• Premature Birth

Intervention

Dietary Supplement:
• Probiotic
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

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario La Paz	Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	clinical features during NICU stay	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	during NICU stay, arround 1 moth	Yes
Primary	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	Yes
Secondary	concentration of immunological parameters on feces	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).	prior to star and at 7th, 14th and 21st days of receiving probiotics	Yes
Secondary	concentration of immunological parameters on plasma samples	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).	7th, 14th, 19th and 24th days of receiving probiotic).	Yes