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Efficacy of Bifidobacterium breve CECT7263 for infantile colic treatment: an open-label, parallel, randomised,
J A Maldonado-Lobón1, R Blanco-Rojo1, J Maldonado2,3,4,5
1Biosearch Life, Camino de Purchil 66, 18004 Granada, Spain.
Insights
Infantile colic, characterized by excessive crying, may find relief with Bifidobacterium breve CECT7263. This probiotic demonstrated a faster and more effective reduction in crying time compared to simethicone in colicky infants.
Area of Science:
- Pediatrics
- Microbiology
- Gastroenterology
Background:
- Infantile colic is a common condition in infants, causing significant distress to both the baby and parents.
- Current treatments for infantile colic lack consistent efficacy, highlighting the need for novel therapeutic approaches.
Purpose of the Study:
- To evaluate the effectiveness of Bifidobacterium breve CECT7263, alone and in combination with Lactobacillus fermentum CECT5716, against simethicone for reducing crying time in colicky infants.
- To compare the onset and magnitude of treatment effects among the different intervention groups.
Main Methods:
- A 28-day, multicentre, randomised, open-label, parallel-controlled trial involving 150 infants diagnosed with colic.
- Infants received either simethicone, Bifidobacterium breve CECT7263 (Bb group), or a combination of Lactobacillus fermentum CECT5716 and Bifidobacterium breve CECT7263 (Bb+Lf group).
- Primary outcomes included daily crying minutes and percentage reduction from baseline; data were analyzed using intention-to-treat.
Main Results:
- All treatment groups showed a significant decrease in daily crying time (P-time <0.001).
- The Bifidobacterium breve CECT7263 group exhibited significantly reduced crying from week 1, while the other groups showed reductions from week 2 (P<0.05).
- The Bb group achieved a significantly higher percentage reduction in crying time compared to the simethicone group throughout the study, with improved infant sleep and parental mood.
Conclusions:
- Bifidobacterium breve CECT7263 is a safe and effective treatment for infantile colic.
- This probiotic strain offers an earlier and more potent therapeutic effect compared to simethicone.
- The findings support the use of Bifidobacterium breve CECT7263 for managing infantile colic, improving infant well-being and parental satisfaction.
Abstract:
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.
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