Safety of D-lactate Producing Probiotics

Acidosis Clinical Trial

Official title:

Safety Assessment of a Starter Formula Containing D-lactate Producing Probiotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119170
• Other study ID #: 09.51.INF
• Status: Completed
• Phase: N/A
• First received: April 27, 2010
• Last updated: April 24, 2012
• Start date: May 2010
• Est. completion date: August 2011

Study information

• Verified date: April 2012
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 1 Day

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acidosis

Intervention

Other:
• Starter formula
standard starter formula given from birth to 6 months of age
• starter formula with D-lactate producing probiotics
starter formula containing probiotics given from birth to 6 months of age

Locations

Country	Name	City	State
Greece	Maternity Helena Venizelou	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	D-lactic acid urine measure in babies		1 month	Yes
Secondary	anthropometric measures (Weight, length, and head circumference, stool microbiota, adverse events		6 months	No