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Efficacy of Bifidobacterium breve CECT7263 for infantile colic treatment: an open-label, parallel, randomised, controlled trial.

  • 2021-02-24
  • Beneficial microbes 12(1)
    • 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

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 150
Population
150 infants who were diagnosed with colic according to the Rome III criteria
Methods
Multicentre randomised, open-label, parallel, controlled trial of 28 days; infants randomly received simethicone (80 mg/day; Simethicone group), B. breve CECT7263 (2×10^8 cfu/day, Bb group), or a combination of L. fermentum CECT5716 and B. breve CECT7263 (1×10^8 cfu/day per strain, Bb+Lf group)
Blinding
Open-label
Duration
28 days
Funding
Unclear
  • Large Human Trial
  • Rigorous Journal
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 <0.001). However, the infants in the Bb group had significantly decreased crying time from the first week of the study (P<0.05), whereas the Bb+Lf group and the simethicone group had significantly decreased crying time from the second week (P<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, P<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 strain B. breve CECT7263 is a safe and effective treatment for infantile colic, presenting an earlier and more robust effect than the reference prescribed drug, simethicone.

Research Insights

  • Lactobacillus fermentum CECT5716→Reduced Crying Time

    the infants in the Bb group had significantly decreased crying time from the first week of the study (P<0.05), whereas the Bb+Lf group and the simethicone group had significantly decreased crying time from the second week (P<0.05).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    1×10^8 cfu/day (as part of combination Bb+Lf group with B. breve CECT7263 at same dose)

Adverse Events Reported

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