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Safety of D-lactate Producing Probiotics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01119170
First received: April 27, 2010
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  Purpose

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).


Condition Intervention
Acidosis
 Other: Starter formula
Other: starter formula with D-lactate producing probiotics

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety Assessment of a Starter Formula Containing D-lactate Producing Probiotics

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • D-lactic acid urine measure in babies [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • anthropometric measures (Weight, length, and head circumference, stool microbiota, adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: May 2010
Study Completion Date: August 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   up to 1 Day
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119170

Locations
Greece
Maternity Helena Venizelou
Athens, Greece
Sponsors and Collaborators
Nestlé
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01119170     History of Changes
Other Study ID Numbers: 09.51.INF
Study First Received: April 27, 2010
Last Updated: April 24, 2012
Health Authority: Greece: Ethics Committee

Keywords provided by Nestlé:
nutrition
infant formula
probiotics

Additional relevant MeSH terms:
Acidosis
Acid-Base Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013