Yvan Vandenplas1, Anca Bacarea2, Marius Marusteri2, Vlad Bacarea2, Mariana Constantin3, Mihai Manolache4. 1. Department of Pediatrics, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium. 2. University of Medicine & Pharmacy Târgu Mureş City, Romania. 3. Private Practice of Family Medicine, Pitesti City, Romania. 4. CEBIS International Ltd, Bucharest, Romania.
Abstract
AIM: Comparing efficacy and safety of APT198K (xyloglucan plus heat-killed Lactobacillusreuteri SGL01 and Bifidobacterium brevisSGB01) versus a lactase dietary supplement as first-line treatment of infantile colic. METHODS: Randomized, multicenter, open-label, parallel group, active-controlled study, in 46 infants aged 3-16 weeks with infantile colic, receiving APT198K or a lactase dietary supplement for 10 days. RESULTS:Number and duration of crying episodes decreased significantly versus baseline in both groups. On day 8, the mean duration of crying per episode was significantly shorter in the APT198K group compared with the lactase group (9.14 ± 5.34 vs 13.22 ± 5.29 min; p = 0.014) and remained so up to day 11. CONCLUSION:APT198K decreased the mean duration per crying episode significantly more than a lactase dietary supplement in infants with colic. Further evaluation in larger studies is warranted. Clinical trial registry: EudraCT number 2014-002860-334; https://eudract.ema.europa.eu .
RCT Entities:
AIM: Comparing efficacy and safety of APT198K (xyloglucan plus heat-killed Lactobacillus reuteri SGL01 and Bifidobacterium brevis SGB01) versus a lactase dietary supplement as first-line treatment of infantile colic. METHODS: Randomized, multicenter, open-label, parallel group, active-controlled study, in 46 infants aged 3-16 weeks with infantile colic, receiving APT198K or a lactase dietary supplement for 10 days. RESULTS: Number and duration of crying episodes decreased significantly versus baseline in both groups. On day 8, the mean duration of crying per episode was significantly shorter in the APT198K group compared with the lactase group (9.14 ± 5.34 vs 13.22 ± 5.29 min; p = 0.014) and remained so up to day 11. CONCLUSION: APT198K decreased the mean duration per crying episode significantly more than a lactase dietary supplement in infants with colic. Further evaluation in larger studies is warranted. Clinical trial registry: EudraCT number 2014-002860-334; https://eudract.ema.europa.eu .
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