Safety of D-lactate Producing Probiotics

Not Applicable

Completed

• Conditions: Acidosis
• Interventions: Other: Starter formula; Other: starter formula with D-lactate producing probiotics

• Registration Number: NCT01119170
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study First Submitted: 2010-04-27
• Study Start: 2010-05
• Study First Submitted QC: 2010-05-05
• Study First Posted: 2010-05-07
• Primary Completion: 2011-03
• Study Completion: 2011-08
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-24
• Last Update Posted: 2012-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control starter formula	Starter formula	-
D-lactate probiotics	starter formula with D-lactate producing probiotics	-

Primary Outcome Measures

Name	Time	Method
D-lactic acid urine measure in babies	1 month

Secondary Outcome Measures

Name	Time	Method
anthropometric measures (Weight, length, and head circumference, stool microbiota, adverse events	6 months

Trial Locations

Locations (1)

Maternity Helena Venizelou; 🇬🇷 Athens, Greece