The Effect of Probiotic Supplement on Urinary D-lactic Acid Level in Newborns

NCT04620629 | Completed

• 1 other identifier: KA-19134
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

It is thought that prophylactic enteral probiotics in newborns may play a role in the prevention of infection and NEC-related morbidity by preventing bacterial migration in the mucosa, reducing their number by competing with pathogenic bacteria, providing microbial balance, and increasing intestinal immunity. In our study, it was determined to detect normal D-lactic acid levels in urine in late premature (babies born after 34 weeks of gestation) and term babies, to show the negative effect of antibiotic treatment on the intestinal flora indirectly by measuring urinary D-lactic acid, and the probiotic support in babies using antibiotics was disrupted. The investigators aim to investigate hypothesis that it will have a corrective effect on the intestinal flora by comparing urinary D-lactic acid levels.

Conditions

Antibiotic Side Effect

Outcome Measures

Primary Outcomes (1)

• urinary D-lactate levels

  Urinary D-lactic acid levels of infants in the subgroup taking probiotics and not taking probiotics will be compared at the end of the 4th week.

  4 weeks

Study Arms (3)

control group

Late premature and term babies without any disease

probiotic group

Babies whose probiotic support is started and continues because they cannot receive breast milk, and whose antibiotic treatment is started in the neonatal period.

antibiotic group

Babies who receives antibiotic treatment in the neonatal period and does not receive probiotic support before.

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Healthy newborns who born after 34 weeks of gestation, late preterm and term infants receiving antibiotic treatment,

You may qualify if:

• Late preterm and term babies
• Babies who are fed only breast milk and / or formula with breast milk
• Babies who have to be given formula support in the early period because they cannot receive breast milk or are not sufficient in the neonatal period, therefore probiotic support is started and continues
• Babies whose antibiotic treatment is started in the neonatal period
• Babies whose parents consent to participate in the study

You may not qualify if:

• Hypoxic ischemic encephalopathy
• Babies with urinary tract infections
• Babies with a history of premature rupture of membranes
• Chromosomal abnormality
• Those with major congenital anomaly, gastrointestinal system anomaly
• Presence of any known immunodeficiency,

Sponsors & Collaborators

• H. Tolga Çelik: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine

Study Officials

• Tolga Celik

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: February 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

TU (1)