Safety of D-lactate Producing Probiotics

Tracking Information
First Submitted Date ICMJE	April 27, 2010
First Posted Date ICMJE	May 7, 2010
Last Update Posted Date	April 25, 2012
Study Start Date ICMJE	May 2010
Actual Primary Completion Date	March 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 5, 2010)	D-lactic acid urine measure in babies [ Time Frame: 1 month ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01119170 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 5, 2010)	anthropometric measures (Weight, length, and head circumference, stool microbiota, adverse events [ Time Frame: 6 months ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety of D-lactate Producing Probiotics
Official Title ICMJE	Safety Assessment of a Starter Formula Containing D-lactate Producing Probiotics
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).
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 ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Acidosis
Intervention ICMJE	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
Study Arms	Placebo Comparator: control starter formula Intervention: Other: Starter formula; Experimental: D-lactate probiotics Intervention: Other: starter formula with D-lactate producing probiotics
Publications *	Garcia Rodenas CL, Lepage M, Ngom-Bru C, Fotiou A, Papagaroufalis K, Berger B. Effect of Formula Containing Lactobacillus reuteri DSM 17938 on Fecal Microbiota of Infants Born by Cesarean-Section. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):681-687.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 5, 2010)	88
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	August 2011
Actual Primary Completion Date	March 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	up to 1 Day (Child)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Greece
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01119170
Other Study ID Numbers ICMJE	09.51.INF
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Nestlé
Study Sponsor ICMJE	Nestlé
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Nestlé
Verification Date	April 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP