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

Sponsor
H. Tolga Çelik (Other)
Overall Status
Recruiting
CT.gov ID
NCT04620629
Collaborator
(none)
90
1
11
8.2

Study Details

Study Description

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. We aim to investigate our hypothesis that it will have a corrective effect on the intestinal flora by comparing urinary D-lactic acid levels.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Lactic acid exists as two optical isomers, L-lactic acid and D-lactic acid. These isomers are metabolized to or synthesized from pyruvate by the action of isomer-specific enzymes (L-lactate dehydrogenase and D-lactate dehydrogenase). Mammals, including humans, do not possess D-lactate dehydrogenase, and therefore D-lactate production in human tissue is very limited. The endogenous single D-lactate synthesis known in man is carried out by glyoxalase. In this pathway, methylglyoxal is converted into D-lactate by the enzymes glyoxalase-1 and glyoxalase-2. Due to this restricted production, the blood D-lactate level in healthy people is so low that L-lactate is the major physiological enantiomer of lactate in the human body.

    The bacterial flora in the human gastrointestinal tract has the ability to produce L and / or D-lactate depending on the amount of L-LDH and D-LDH present. Some strains of bacteria have the enzyme DL-lactate racemase to convert one isomer to another. Therefore, racemization reactions can further increase the amount of D-lactate isomers present in the column. Although there is no D-lactate dehydrogenase enzyme in humans, D-Lactate is metabolized into pyruvate by the enzyme D-2-hydroxy acid dehydrogenase (D-2-HDH), an intramitochondrial flavoprotein with high activity in the liver and renal cortex. The kidney's threshold for D-lactate is much lower than L-lactate and is efficiently excreted in urine as well as metabolic clearance. Thus, under normal conditions, D-lactate produced by tissue metabolism or bacterial fermentation in the gut; It does not cause a clinically significant increase in lactate in blood, urine or feces.

    D-lactic acidosis is a well-defined complication of short bowel syndrome due to the combination of altered gastrointestinal tract anatomy and abnormal bacterial flora. Many case reports reported in the literature are associated with short bowel syndrome secondary to various causes. There are studies investigating the effects of fermented formulas and probiotics on D-lactic acid in healthy babies. In these studies, no increased risk for D-lactic acidosis was found in healthy infants fed with probiotic supplemented formulas.

    Considering the studies on newborns; In babies with necrotizing enterocolit, it has been shown that urinary D-lactate excretion increased as a result of increased enteric bacterial activity. In another study, plasma D-lactic acid level was found to be high in premature babies with necrotizing enterocolitis. However, more detailed studies on newborns are needed.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Effect of Probiotic Supplement on Urinary D-lactic Acid Level in Newborns Receiving Antibiotic Treatment
    Actual Study Start Date :
    Feb 1, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2020
    Anticipated Study Completion Date :
    Dec 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. urinary D-lactate levels [4 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 28 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • 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,

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hacettepe University Ankara Turkey

    Sponsors and Collaborators

    • H. Tolga Çelik

    Investigators

    • Principal Investigator: Tolga Celik, Hacettepe University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    H. Tolga Çelik, Principal Investigator, Hacettepe University
    ClinicalTrials.gov Identifier:
    NCT04620629
    Other Study ID Numbers:
    • KA-19134
    First Posted:
    Nov 9, 2020
    Last Update Posted:
    Nov 9, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 9, 2020