Clinical Trial: Safety of D-lactate Producing Probiotics

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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, gastrointes
Sponsor: Nestlé

Current Primary Outcome: D-lactic acid urine measure in babies [ Time Frame: 1 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome: anthropometric measures (Weight, length, and head circumference, stool microbiota, adverse events [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: Nestlé

Dates:
Date Received: April 27, 2010
Date Started: May 2010
Date Completion:
Last Updated: April 24, 2012
Last Verified: April 2012