Abstract Title:

Efficacy ofCECT7263 for infantile colic treatment: an open-label, parallel, randomised, controlled trial.

Abstract Source:

Benef Microbes. 2021 Feb 24 ;12(1):55-67. Epub 2020 Dec 22. PMID: 33350361

Abstract Author(s):

J A Maldonado-Lobón, R Blanco-Rojo, J Maldonado, M A Ali, M V Almazán, A Suanes-Cabello, E Callejón, R Jaldo, M R Benavídes, A M Negrillo, A Sañudo, C Rodríguez, O Bañuelos, J Fonollá, M Olivares,

Article Affiliation:

J A Maldonado-Lobón


Infantile colic is a prevalent condition characterised by excessive crying with no effective treatment available. We aimed to evaluate the efficacy ofCECT7263 and a combination of this andCECT5716 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),CECT7263 (2×10cfu/day, Bb group), or a combination ofCECT5716 andCECT7263 (1×10cfu/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 (-time<0.001). However, the infants in the Bb group had significantly decreased crying time from the first week of the study (<0.05), whereas the Bb+Lf group and the simethicone group had significantly decreased crying time from the second week (<0.05). The percentage of reduction in the minutes of crying from baseline in the Bb group was significantly higher than that in the Simethicone group every week of the intervention (-40.3 vs -27.6% at 1-week; -59.2 vs -43.2% at 2-weeks; -64.5 vs -53.5% at 3-week and -68.5 vs -59.5% at 4-weeks,<0.05). Additionally, in the Bb group, infants had better night sleep, and parents reported a more positive mood at the end of the intervention. All the products used in the study were safe and well tolerated. In conclusion, the breastmilk-isolated probiotic strainCECT7263 is a safe and effective treatment for infantile colic, presenting an earlier and more robust effect than the reference prescribed drug, simethicone.

Study Type : Human Study

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