Safety of D-lactate Producing Probiotics

Safety Assessment of a Starter Formula Containing D-lactate Producing Probiotics

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).

Study Overview

• Status: Completed
• Conditions: Acidosis
• Intervention / Treatment: Other: Starter formula; Other: starter formula with D-lactate producing probiotics

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • Maternity Helena Venizelou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
D-lactic acid urine measure in babies	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
anthropometric measures (Weight, length, and head circumference, stool microbiota, adverse events	6 months

Collaborators and Investigators

• Sponsor: Nestlé

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: April 27, 2010
• First Submitted That Met QC Criteria: May 5, 2010
• First Posted (Estimate): May 7, 2010

Study Record Updates

• Last Update Posted (Estimate): April 25, 2012
• Last Update Submitted That Met QC Criteria: April 24, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: nutrition; probiotics; infant formula
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis
• Other Study ID Numbers: 09.51.INF