Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

April 27, 2010
April 24, 2012
May 2010
March 2011   (final data collection date for primary outcome measure)
D-lactic acid urine measure in babies [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01119170 on ClinicalTrials.gov Archive Site
anthropometric measures (Weight, length, and head circumference, stool microbiota, adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acidosis
  • Other: Starter formula
    standard starter formula given from birth to 6 months of age
  • Other: starter formula with D-lactate producing probiotics
    starter formula containing probiotics given from birth to 6 months of age
  • Placebo Comparator: control starter formula
    Intervention: Other: Starter formula
  • Experimental: D-lactate probiotics
    Intervention: Other: starter formula with D-lactate producing probiotics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
August 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
up to 1 Day
Yes
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01119170
09.51.INF
No
Nestlé
Nestlé
Not Provided
Not Provided
Nestlé
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP