Safety of D-lactate Producing Probiotics

NCT ID: NCT01119170

Last Updated: 2012-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-08-31

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.

Conditions

Acidosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

control starter formula

Group Type: PLACEBO_COMPARATOR

Starter formula

Intervention Type: OTHER

standard starter formula given from birth to 6 months of age

D-lactate probiotics

Group Type: EXPERIMENTAL

starter formula with D-lactate producing probiotics

Intervention Type: OTHER

starter formula containing probiotics given from birth to 6 months of age

Interventions

Starter formula

standard starter formula given from birth to 6 months of age

Intervention Type: OTHER

starter formula with D-lactate producing probiotics

starter formula containing probiotics given from birth to 6 months of age

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 1 Day
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maternity Helena Venizelou

Athens, , Greece

Countries

Greece

References

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.

Reference Type: DERIVED

PMID: 27035371 (View on PubMed)

Other Identifiers

09.51.INF

Identifier Type: -

Identifier Source: org_study_id