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. |
ClinicalTrials.gov Identifier: NCT01119170 |
Recruitment Status
:
Completed
First Posted
: May 7, 2010
Last Update Posted
: April 25, 2012
|
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 |
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 |
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 |
|
||
Study Arms |
|
||
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 |
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:
Exclusion Criteria:
|
||
Sex/Gender |
|
||
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 |