Safety of D-lactate Producing Probiotics
Information source: Nestlé Nutrition Corporate
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acidosis
Intervention: Starter formula (Other); starter formula with D-lactate producing probiotics (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Nestlé Nutrition Corporate Overall contact:
Konstantinos Papagaroufalis, Prof, Phone: +30 210 646 7165, Email: elpapgar@yahoo.gr
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).
Clinical Details
Official title: Safety Assessment of a Starter Formula Containing D-lactate Producing Probiotics
Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: D-lactic acid urine measure in babies
Secondary outcome: anthropometric measures (Weight, length, and head circumference, stool microbiota, adverse events
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
Minimum age: N/A.
Maximum age: 1 Day.
Gender(s): Both.
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
Locations and Contacts
Konstantinos Papagaroufalis, Prof, Phone: +30 210 646 7165, Email: elpapgar@yahoo.gr
Maternity Helena Venizelou, Athens, Greece; Recruiting
Konstantinos Papagaroufalis, Prof, Phone: +30 210 646 7165, Email: elpapgar@yahoo.gr
Konstantinos Papagaroufalis, Prof, Principal Investigator
Additional Information
Starting date: May 2010
Last updated: May 18, 2010
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