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

Madrid Health Service

Status and phase: Completed; Early Phase 1

Conditions: NEC; Other Preterm Infants

Treatments: Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT02192996

Universidad Complutense Madrid (Other Identifier)

HULP3551

Details and patient eligibility

About

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).

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 1 hour to 1 week old

Volunteers: No Healthy Volunteers

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

Trial design

5 participants in 1 patient group

Probiotics supplementation

Other group

Description:

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.

Treatment:

Dietary Supplement: Probiotic