Antibiotic Side EffectNCT04620629
The Effect of Probiotic Supplement on Urinary D-lactic Acid Level in Newborns
An observational study of Antibiotic Side Effect, run by H. Tolga Çelik at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Antibiotic Side Effect
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Healthy newborns who born after 34 weeks of gestation, late preterm and term infants receiving antibiotic treatment,
Who may be able to join
- 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
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Probiotic Supplement on Urinary D-lactic Acid Level in Newborns Receiving Antibiotic Treatment
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.
Read the 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.
- Conditions
- Antibiotic Side Effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Feb 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic Side EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Tolga Çelik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, H. Tolga Çelik, Hacettepe University
- Investigators
- Tolga Celik, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620629
- Sponsor's protocol ID
- KA-19134
- Status last verified
- Mar 2023
- First submitted
- 3 Nov 2020
- Last updated
- 6 Mar 2023
- Results posted
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotic Supplement on Urinary D-lactic Acid Level in Newborns Receiving Antibiotic Treatment
- ClinicalTrials.gov ID
- NCT04620629
- Acronym / sponsor ID
- KA-19134
- Conditions
- Antibiotic Side Effect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- H. Tolga ÇelikUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Healthy newborns who born after 34 weeks of gestation, late preterm and term infants receiving antibiotic treatment,
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
urinary D-lactate levels
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tolga Celik principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Side Effect, run by H. Tolga Çelik at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinary D-lactate levels (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.