RT Journal Article T1 Efficacy of Bifidobacterium breve CECT7263 for infantile colic treatment: an open-label, parallel, randomised, controlled trial. A1 Maldonado-Lobon, J A A1 Blanco-Rojo, R A1 Maldonado, J A1 Ali, M A A1 Almazan, M V A1 Suanes-Cabello, A A1 Callejon, E A1 Jaldo, R A1 Benavides, M R A1 Negrillo, A M A1 Sañudo, A A1 Rodriguez, C A1 Bañuelos, O A1 Fonolla, J A1 Olivares, M K1 bifidobacteria K1 infant colic K1 paediatric population K1 probiotics AB Infantile colic is a prevalent condition characterised by excessive crying with no effective treatment available. We aimed to evaluate the efficacy of Bifidobacterium breve CECT7263 and a combination of this and Lactobacillus fermentum CECT5716 versus simethicone in reducing the daily time spent crying in colicky infants. A multicentre randomised, open-label, parallel, controlled trial of 28 days was performed in 150 infants who were diagnosed with colic according to the Rome III criteria and who randomly received simethicone (80 mg/day; Simethicone group), B. breve CECT7263 (2×108 cfu/day, Bb group), or a combination of L. fermentum CECT5716 and B. breve CECT7263 (1×108 cfu/day per strain, Bb+Lf group). The main outcomes were minutes of crying per day and the percentage of reduction in daily crying from baseline. Data were analysed per intention to treat. All treatments significantly decreased the daily crying time at the end of the intervention (P-time PB Brill - Wageningen Academic Publishers YR 2020 FD 2020-09-16 LK http://hdl.handle.net/10668/16831 UL http://hdl.handle.net/10668/16831 LA en NO Maldonado-Lobón JA, Blanco-Rojo R, Maldonado J, Ali MA, Almazán MV, Suanes-Cabello A, et al. Efficacy of Bifidobacterium breve CECT7263 for infantile colic treatment: an open-label, parallel, randomised, controlled trial. Benef Microbes. 2021 Feb 24;12(1):55-67. DS RISalud RD Apr 4, 2025