Safety of D-lactate Producing Probiotics

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety Assessment of a Starter Formula Containing D-lactate Producing Probiotics

Conditions
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Acidosis

Intervention / Treatment
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* Other: Starter formula
* Other: starter formula with D-lactate producing probiotics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control starter formula<br> | Other: Starter formula<br>* standard starter formula given from birth to 6 months of age<br>|
| Experimental: D-lactate probiotics<br> | Other: starter formula with D-lactate producing probiotics<br>* starter formula containing probiotics given from birth to 6 months of age<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| D-lactic acid urine measure in babies |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anthropometric measures (Weight, length, and head circumference, stool microbiota, adverse events |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition, infant formula, probiotics