Clinical trial NCT01119170: Safety of D-lactate Producing Probiotics
Official title: Safety Assessment of a Starter Formula Containing D-lactate Producing Probiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acidosis
Keywords: nutrition
infant formula
probiotics
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2010-05-07
Enrollment: 88
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: D-lactic acid urine measure in babies
timeFrame: 1 month
Secondary outcomes:
measure: anthropometric measures (Weight, length, and head circumference, stool microbiota, adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Maternity Helena Venizelou
Study officials:
References:
citation: Garcia Rodenas CL, Lepage M, Ngom-Bru C, Fotiou A, Papagaroufalis K, Berger B. Effect of Formula Containing Lactobacillus reuteri DSM 17938 on Fecal Microbiota of Infants Born by Cesarean-Section. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):681-687. doi: 10.1097/MPG.0000000000001198.