Indrio F, 2011
Italy
To evaluate the efficacy of L. reuteri DSM 17938 on gastric function in full term formula-fed infants with ≥ 4 regurgitation episodes/day.
R, DB, PC 30 days
L. reuteri: 19 (1×108 CFU) Placebo: 15
• L. reuteri significantly reduced regurgitation episodes by 50%
• L. reuteri significantly increased gastric emptying rate at 30 days compared to baseline
Papagaroufalis K, 2014
Greece
To assess the safety of infant formula containing L. reuteri DSM 17938 during the first month of life, with special reference to D-lactic acid, in comparison to infants fed a control formula. Other outcomes were GI tolerance, sleeping and crying behaviour, growth and oc currence of adverse events.
R, DB, PC 28 days
Follow-up on days 112 and 168
L. reuteri: 36 (1×108 CFU) Control: 35
31 infants in each group took part in the follow-up on days 112 and 168
Compared to control formula:
• Regurgitation episodes were significantly fewer in the L. reuteri group
• The probiotic group had significantly lower frequency of hard stools and higher percentage of soft stools at day 28
Indrio F, 2017
Italy
To evaluate the efficacy of a partially hydrolyzed whey protein formula containing additional starch and L. reuteri (Lr) on frequency of regurgitation and gastric emptying in infants with functional regur gitation. Gastric emptying rate (GErate), measured by ultrasound, was defined as reduction in antral cross-sectional area in relation to ingestion of meal, at time 0 and after 120 min.
R, DB, PC 4 weeks
Thickened, partially hydrolyzed formula + L. reuteri: 37 (2.8x 106 CFU/g powder) Standard formula: 35
Compared to control, L. reuteri significantly reduced daily regurgitations (baseline vs. day 28):
• 7.4 vs. 2.6 in the Lr group
• 7.5 vs. 5.3 in control group GErate percentage change between week 0 and week 4 was significantly higher in the L. reuteri group compared to controls: median 12.3% and 9.1%, respectively.