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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014