Safety of D-lactate Producing Probiotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01119170
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : April 25, 2012
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Acidosis Other: Starter formula Other: starter formula with D-lactate producing probiotics Not Applicable

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  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety Assessment of a Starter Formula Containing D-lactate Producing Probiotics
Study Start Date : May 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. D-lactic acid urine measure in babies [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. anthropometric measures (Weight, length, and head circumference, stool microbiota, adverse events [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01119170

Maternity Helena Venizelou
Athens, Greece
Sponsors and Collaborators

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nestlé Identifier: NCT01119170     History of Changes
Other Study ID Numbers: 09.51.INF
First Posted: May 7, 2010    Key Record Dates
Last Update Posted: April 25, 2012
Last Verified: April 2012

Keywords provided by Nestlé:
infant formula

Additional relevant MeSH terms:
Acid-Base Imbalance
Metabolic Diseases