NEC, Other Preterm Infants
Conditions
Keywords
VLBW preterm, GUT microbiota, probiotics supplementation, immune compounds
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
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
Sponsors
Universidad Complutense de Madrid
Hospital Universitario La Paz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Hours to 1 Weeks
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in microbiological counts in feces of preterm infants | 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
| Measure | Time frame | Description |
|---|---|---|
| concentration of immunological parameters on feces | 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). |
| concentration of immunological parameters on plasma samples | 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
| Measure | Time frame | Description |
|---|---|---|
| clinical features during NICU stay | 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 |
Countries
Spain
Outcome results
None listed