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Evidence-Based Supplement Research
Evidence-Based Supplement Research

Effect of early probiotic supplementation on childhood cognition, behaviour and mood a randomised, placebo-controlled trial.

  • 2018-10-22
  • Acta paediatrica (Oslo, Norway : 1992) 107(12)

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 474
Population
342 children at risk of developing allergic disease, assessed at 11 years of age
Methods
Two-centre randomised placebo-controlled trial of Lactobacillus rhamnosus HN001, Bifidobacterium animalis subsp. lactis HN019 or placebo from 35 weeks gestation to 6 months (mothers) and from birth to 2 years (infants)
Duration
2 years
Funding
Unclear
  • Large Human Trial

Aim

To determine whether probiotic supplementation in early life improves neurocognitive outcomes assessed at 11 years of age.

Methods

A total of 474 children who were born March 2004-Aug 2005 participated in a two-centre randomised placebo-controlled trial of infants at risk of developing allergic disease. Pregnant women were randomised to take Lactobacillus rhamnosus strain HN001, Bifidobacterium animalis subsp. lactis strain HN019 or placebo daily from 35 weeks gestation until six months if breastfeeding, and their infants the same treatment from birth to two years. Intelligence, executive function, attention, depression and anxiety were assessed when the children were 11 years of age.

Results

A total of 342 (72.2%) children were assessed (HN001 n = 109, HN019 n = 118 and placebo n = 115). Overall, there were no significant differences in the neurocognitive outcomes between the treatment groups.

Conclusion

HN001 and HN019 given in early life were not associated with neurocognitive outcomes at 11 years of age in this study. However, we cannot exclude that other probiotics may have a beneficial effect. Further clinical trials are indicated.

Research Insights

  • Overall, there were no significant differences in the neurocognitive outcomes between the treatment groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    daily from 35 weeks gestation until six months if breastfeeding, and the same treatment from birth to two years
  • Overall, there were no significant differences in the neurocognitive outcomes between the treatment groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    daily from 35 weeks gestation until six months if breastfeeding, and the same treatment from birth to two years
  • Overall, there were no significant differences in the neurocognitive outcomes between the treatment groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    daily from 35 weeks gestation until six months if breastfeeding, and the same treatment from birth to two years
  • Overall, there were no significant differences in the neurocognitive outcomes between the treatment groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    daily from 35 weeks gestation until six months if breastfeeding, and the same treatment from birth to two years
  • Overall, there were no significant differences in the neurocognitive outcomes between the treatment groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    daily from 35 weeks gestation until six months if breastfeeding, and the same treatment from birth to two years
  • Overall, there were no significant differences in the neurocognitive outcomes between the treatment groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    daily from 35 weeks gestation until six months if breastfeeding, and the same treatment from birth to two years
  • Overall, there were no significant differences in the neurocognitive outcomes between the treatment groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    daily from 35 weeks gestation until six months if breastfeeding, and the same treatment from birth to two years
  • Overall, there were no significant differences in the neurocognitive outcomes between the treatment groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    daily from 35 weeks gestation until six months if breastfeeding, and the same treatment from birth to two years
  • Overall, there were no significant differences in the neurocognitive outcomes between the treatment groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    daily from 35 weeks gestation until six months if breastfeeding, and the same treatment from birth to two years
  • Overall, there were no significant differences in the neurocognitive outcomes between the treatment groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    daily from 35 weeks gestation until six months if breastfeeding, and the same treatment from birth to two years
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