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Bifidobacterium longum subsp infantis CECT7210-supplemented formula reduces diarrhea in healthy infants: a randomized controlled trial

  • 2018-05-02
  • Pediatric Research 83(6)
    • J. Escribano
    • N. Ferré
    • M. Gispert-Llauradó
    • V. Luque
    • C. Rubio-Torrents
    • M. Zaragoza-Jordana
    • I. Polanco
    • F. Codoñer
    • E. Chenoll
    • M. Morera
    • J. A. Moreno-Muñoz
    • M. Rivero
    • R. Closa-Monasterolo

Abstract

BackgroundIntestinal microbiota of breast-fed infants is plenty of beneficial bifidobacteria. We aimed to determine whether an infant formula supplemented with probiotic Bifidobacterium longum subsp. infantis CECT7210 (B. infantis IM1) is effective at reducing diarrhea incidence in healthy term infants.MethodsDouble-blinded, randomized, multicenter, controlled clinical trial, where formula-fed infants (<3 months) received an infant formula supplemented (Probiotic) or not (Control) with 107 cfu/g of B. infantis IM1 over 12 weeks. Diarrheas, growth, digestive symptoms, stool bifidobacteria, and microbiota were assessed.ResultsIn all, 97 (Control) and 93 (Probiotic) infants were randomized, and 78 (Control) and 73 (Probiotic) completed the 12 week-follow-up. In the overall study period, a median of 0.29±1.07 and 0.05±0.28 diarrhea events/infant was observed in the Control and Probiotic groups, respectively (P=0.059). This trend to less diarrhea episodes in the Probiotic group reached statistical significance at 8 weeks (0.12±0.47 vs. 0.0±0.0 events/infant, P=0.047). Constipation incidence was higher (odds ratio (OR) 2.67 (1.09-6.50)) and stool frequency lower (2.0±1.0 vs. 2.6±1.3 stools/day, P=0.038) in the Control group after 4 weeks. No differences were found at other time points nor in other digestive symptoms, growth, or formula intake.ConclusionA B. infantis IM1-supplemented infant formula may reduce diarrhea episodes, being safe, well tolerated, and associated with lower constipation prevalence.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Bifidobacterium infantisReduced Diarrhea IncidenceBeneficial
Moderate
Bifidobacterium infantisReduced Incidence of ConstipationBeneficial
Moderate
Bifidobacterium infantis BI02Increased Constipation RiskHarmful
Moderate
Bifidobacterium infantis BI02Reduced Diarrhea IncidenceBeneficial
Moderate
Bifidobacterium infantis Bi-26Increased Constipation RiskHarmful
Moderate
Bifidobacterium infantis Bi-26Reduced Diarrhea IncidenceBeneficial
Moderate
Bifidobacterium infantis HA-116Reduced Diarrhea IncidenceBeneficial
Moderate
Bifidobacterium infantis HA-116Reduced Incidence of ConstipationBeneficial
Moderate
Bifidobacterium infantis M-63Increased Constipation RiskHarmful
Moderate
Bifidobacterium infantis M-63Reduced Diarrhea IncidenceBeneficial
Moderate
Bifidobacterium infantis MAK22B041Increased Constipation RiskHarmful
Moderate
Bifidobacterium infantis MAK22B041Reduced Diarrhea IncidenceBeneficial
Moderate
Bifidobacterium infantis MAK22B04IIncreased Constipation RiskHarmful
Moderate
Bifidobacterium infantis MAK22B04IReduced Diarrhea IncidenceBeneficial
Moderate
Bifidobacterium infantis SD-6720No Impact on Digestive Symptoms, Growth, or Formula IntakeNeutral
Small
Bifidobacterium infantis SD-6720Reduced Constipation PrevalenceBeneficial
Moderate
Bifidobacterium infantis SD-6720Reduced Diarrhea IncidenceBeneficial
Moderate
Bifidobacterium infantis VPro 53Increased Constipation RiskHarmful
Moderate
Bifidobacterium infantis VPro 53Reduced Diarrhea IncidenceBeneficial
Moderate
Bifidobacterium infantis VPro 53Reduced Stool FrequencyNeutral
Small
Bifidobacterium longum B1-05Increased Constipation RiskHarmful
Moderate
Bifidobacterium longum B1-05Reduced Diarrhea IncidenceBeneficial
Moderate
Bifidobacterium longum BI-05Increased Constipation RiskHarmful
Moderate
Bifidobacterium longum BI-05Reduced Diarrhea IncidenceBeneficial
Moderate
Bifidobacterium longum BI-05Reduced Incidence of ConstipationBeneficial
Moderate
Bifidobacterium longum BL03Increased Constipation RiskHarmful
Moderate
Bifidobacterium longum BL03Reduced Diarrhea IncidenceBeneficial
Moderate
Bifidobacterium longum subsp. infantisIncreased Constipation RiskHarmful
Moderate
Bifidobacterium longum subsp. infantisReduced Diarrhea IncidenceBeneficial
Moderate
Bifidobacterium longum subsp. infantisReduced Incidence of ConstipationBeneficial
Moderate
Bifidobacterium longum subsp. infantis M-63Increased Constipation RiskHarmful
Moderate
Bifidobacterium longum subsp. infantis M-63No Significant Change in Gastrointestinal SymptomsNeutral
Small
Bifidobacterium longum subsp. infantis M-63Reduced Diarrhea IncidenceBeneficial
Moderate
Bifidobacterium longum subsp. longumIncreased Constipation RiskHarmful
Moderate
Bifidobacterium longum subsp. longumReduced Diarrhea IncidenceBeneficial
Moderate
Bifidobacterium longum subsp. longumReduced Stool FrequencyNeutral
Small
Bifidobacterium longum subsp. longum UABI-14Increased Constipation RiskHarmful
Moderate
Bifidobacterium longum subsp. longum UABI-14Reduced Diarrhea IncidenceBeneficial
Moderate
Bifidobacterium longum subsp. longum UABI-14Reduced Stool FrequencyNeutral
Small
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