Safety of D-lactate Producing Probiotics
|ClinicalTrials.gov Identifier: NCT01119170|
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : April 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Acidosis||Other: Starter formula Other: starter formula with D-lactate producing probiotics||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Safety Assessment of a Starter Formula Containing D-lactate Producing Probiotics|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||August 2011|
|Placebo Comparator: control starter formula||
Other: Starter formula
standard starter formula given from birth to 6 months of age
|Experimental: D-lactate probiotics||
Other: starter formula with D-lactate producing probiotics
starter formula containing probiotics given from birth to 6 months of age
- D-lactic acid urine measure in babies [ Time Frame: 1 month ]
- anthropometric measures (Weight, length, and head circumference, stool microbiota, adverse events [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119170
|Maternity Helena Venizelou|