PMID- 24812520
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140509
LR  - 20211021
IS  - 1178-6388 (Print)
IS  - 1178-6388 (Electronic)
IS  - 1178-6388 (Linking)
VI  - 7
DP  - 2014
TI  - A Randomized Double Blind Controlled Safety Trial Evaluating d-Lactic Acid 
      Production in Healthy Infants Fed a Lactobacillus reuteri-containing Formula.
PG  - 19-27
LID - 10.4137/NMI.S14113 [doi]
AB  - BACKGROUND: d-Lactic acidosis in infants fed lactic acid bacteria-containing 
      products is a concern. METHODS: The primary objective of this non-inferiority 
      trial was to compare urinary d-lactic acid concentrations during the first 28 
      days of life in infants fed formula containing Lactobacillus reuteri (1.2 x 10(6) 
      colony forming units (CFU)/ml) with those fed a control formula. The 
      non-inferiority margin was set at a two-fold increase in d-lactic acid (0.7 
      mmol/mol creatinine, log-transformed). Healthy term infants in Greece were 
      enrolled between birth and 72 hours of age, and block randomized to a probiotic 
      (N = 44) or control (N = 44) group. They were exclusively fed their formulae 
      until 28 days of age and followed up at 7, 14, 28, 112, and 168 +/- 3 days. 
      Anthropometric measurements were taken at each visit and tolerance recorded until 
      112 days. Urine was collected before study formula intake and at all visits up to 
      112 days and blood at 14 days. RESULTS: d-Lactic acid concentration in the 
      probiotic group was below the non-inferiority margin at 28 days: treatment effect 
      -0.03 (95% confidence interval [CI]: [-0.48 to 0.41]) mmol/mol creatinine but was 
      above the non-inferiority margin at 7 and 14 days-treatment effect 0.50 (95% CI: 
      [0.05-0.96]) mmol/mol creatinine and 0.45 (95% CI: [0.00-0.90]) mmol/mol 
      creatinine, respectively. Blood acid excess and pH, anthropometry, tolerance, and 
      adverse events (AEs) were not significantly different between groups. CONCLUSION: 
      Intake of L. reuteri-containing formula was safe and did not cause an increase in 
      d-lactic acid beyond two weeks.
FAU - Papagaroufalis, Konstantinos
AU  - Papagaroufalis K
AD  - Maternity Helena Venizelou, Athens, Greece.
FAU - Fotiou, Aikaterini
AU  - Fotiou A
AD  - Maternity Helena Venizelou, Athens, Greece.
FAU - Egli, Delphine
AU  - Egli D
AD  - Nestec Ltd, Vevey, Switzerland.
FAU - Tran, Lien-Anh
AU  - Tran LA
AD  - Nestec Ltd, Vevey, Switzerland.
FAU - Steenhout, Philippe
AU  - Steenhout P
AD  - Nestec Ltd, Vevey, Switzerland.
LA  - eng
PT  - Journal Article
DEP - 20140422
PL  - United States
TA  - Nutr Metab Insights
JT  - Nutrition and metabolic insights
JID - 101550186
PMC - PMC3999946
OTO - NOTNLM
OT  - Lactobacillus reuteri
OT  - acidosis
OT  - d-lactic acid
OT  - infant
EDAT- 2014/05/09 06:00
MHDA- 2014/05/09 06:01
PMCR- 2014/04/22
CRDT- 2014/05/10 06:00
PHST- 2014/01/06 00:00 [received]
PHST- 2014/03/10 00:00 [revised]
PHST- 2014/03/10 00:00 [accepted]
PHST- 2014/05/10 06:00 [entrez]
PHST- 2014/05/09 06:00 [pubmed]
PHST- 2014/05/09 06:01 [medline]
PHST- 2014/04/22 00:00 [pmc-release]
AID - nmi-7-2014-019 [pii]
AID - 10.4137/NMI.S14113 [doi]
PST - epublish
SO  - Nutr Metab Insights. 2014 Apr 22;7:19-27. doi: 10.4137/NMI.S14113. eCollection 
      2014.