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

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ClinicalTrials.gov Identifier: NCT02192996
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : July 17, 2014
Sponsor:
Collaborator:
Universidad Complutense de Madrid
Information provided by (Responsible Party):
Esperanza Escribano, Hospital Universitario La Paz

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).

Condition or disease Intervention/treatment Phase
Other Preterm Infants NEC Dietary Supplement: Probiotic Early Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Probiotic Supplementation to Improve the GUT Microbiota of Very Low Birth Weight, a Pilot Study
Study Start Date : December 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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
Other Name: "Bifidobacterium breve / Lactobacillus salivarius mixture"




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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




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Ages Eligible for Study:   up to 1 Week   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02192996


Locations
Spain
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Hospital Universitario La Paz
Universidad Complutense de Madrid
Investigators
Principal Investigator: Miguel Saenz de Pipaon, PhD. MD. Hospital Universitario La Paz

Responsible Party: Esperanza Escribano, Medical doctor, Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT02192996     History of Changes
Other Study ID Numbers: HULP3551
Universidad Complutense Madrid ( Other Identifier: Academic )
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: July 17, 2014
Last Verified: July 2014

Keywords provided by Esperanza Escribano, Hospital Universitario La Paz:
VLBW preterm
GUT microbiota
probiotics supplementation
immune compounds

Additional relevant MeSH terms:
Premature Birth
Birth Weight
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Body Weight
Signs and Symptoms