Acidosis
Conditions
Keywords
nutrition, infant formula, probiotics
Brief summary
In this study the investigators want to test the safety of D-lactate producing probiotics in babies from birth to 1 month of age. Previous data demonstrated no increase in urinary D-lactate in 4 month old infants supplemented with D-lactate producing probiotics. The primary purpose of this study is to evaluate the influence of D-lactate producing probiotics on D-lactate excretion in young infants during the neonatal period (days 0 - 28).
Detailed description
Lactate, in addition to being found in more common fermented foods of today, such as yogurt, lactate, in its two stereoisomer forms, known as the D (dextrorotary) or L (levorotary) is also produced in the colon through the normal fermentative process of lactic acid producing bacteria. Both D-lactate and L-lactate produced by these microbes are metabolized by enzymes within human cells and do not typically pose an acid-base risk by reducing pH to a threatening degree in healthy individuals. However, the specific dehydrogenase that converts D-lactate to pyruvate is far less active than that for L-lactate, and it has been suggested that very young infants may be a vulnerable group for D-lactic acidosis. Previous data have shown that urinary D-/L- lactate excretion were not significantly different between 2 groups of 4 month old infants taking a control formula or a formula containing D-lactate producing probiotics for 4 weeks. However, measures were not collected in babies during the first month after birth. In this study we want to test the safety of D-lactate producing bacteria in babies from birth to 1 month of age. This safety study is a randomized, controlled, single center, clinical trial of 2 groups of infants. The primary objective of this clinical trial is: to evaluate the effect of a starter formula containing D-lactate producing probiotics versus a starter formula without probiotics, on D-lactic acid urine levels in healthy formula-fed infants, from birth to 28 days of age. Urinary D-lactate concentration (mmol/mol creatinine), will be measured at (baseline, 7 days, 14 days and 28 days). Secondary objectives include evaluation of effects on gut microbiota, gastrointestinal tolerance, duration of sleep and crying, morbidity and growth, with a follow up to 6 months of age.
Interventions
OTHERStarter formula
standard starter formula given from birth to 6 months of age
OTHERstarter formula with D-lactate producing probiotics
starter formula containing probiotics given from birth to 6 months of age
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Hours to 1 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy babies, full term (≥37 weeks gestation) who are 0-24 hours of age at enrolment. * Babies anticipated to be exclusively formula-fed. * Babies under the care of a paediatrician or other qualified healthcare professional and have had at least one postnatal visit. * Study explained and written information provided to Parent/Caregiver demonstrating understanding of the given information. * Informed consent signed (parent/legal representative)
Exclusion criteria
* Babies with chromosomal or major congenital anomalies. * Significant pre natal and/or post natal disease * Babies receiving an antibiotic * Babies born from mothers using supplemental probiotics during the last trimester of pregnancy and/or antibiotics during the last 14 days of pregnancy. * Babies' family, of whom in the investigator's assessment, cannot be expected to comply with the protocol. * Babies currently participating in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| D-lactic acid urine measure in babies | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| anthropometric measures (Weight, length, and head circumference, stool microbiota, adverse events | 6 months |
Countries
Greece
Outcome results
None listed