In the trial 57 children aged three to five were given Lactobacillus and Bifidobacterium probiotic strains and vitamin C, observed for six months showing a 33% reduction in the incidence of upper respiratory tract infection (URTI) and a 30% reduction in the number of missed school days.
Nigel Plummer, research leader and MD of Welsh firm and trial sponsor, Cultech, pointed to another meta-analysis published in April this year (King et al), which examined 20 trials involving children, adults and the impact of probiotics on the intensity and duration of URTI.
“The conclusion of that analysis was that probiotics led to a decrease in intensity and duration of 30%,” he said. “That’s quite a consistent effect, and I don’t think the traditional combination of vitamin C and zinc, for instance, achieves that kind of consistency. Our trial has confirmed that effect – and more. We looked at practical outcomes including absence from pre-school, visits to the doctor, the use of antibiotics and other medication.”
Measuring ‘harder’ outcomes
As well as the incidence rate of URTI and the number of school days missed, the number of days of use of antibiotics, painkillers, cough medicine or nasal sprays was lower in the active group and “reached significance for the use of cough medicine”, wrote the researchers.
“Previously, a lot of trials had simply looked at the rather more subjective area of symptoms rather than at ‘harder’ outcomes such as absenteeism or use of medication,” said Plummer.
Cultech, which also trades under the name Proven Probiotics, planned the trial to support a new children’s supplement called Fit For School, which uses the same combination of probiotic strains and 50mg of vitamin C.
Plummer explained that, although the company is able to use the established Proven Probiotics name, it has moved away from the use of the term ‘probiotic’ elsewhere in its labelling as it is not currently authorised under the EU Nutrition and Health Claims Regulation (NHCR).
“The EU regulators will not allow us to use the term ‘probiotic’ to describe our products,” he said. “We have resisted changing this, but now we will.”
The inclusion of vitamin C permits an immune claim however, something Plummer questioned.
“We think that the European Food Safety Authority (EFSA) is fundamentally wrong to suggest that just 15% of the reference daily intake (RDI) of vitamins and minerals will have an effect. I’m completely baffled by this approach to science. At the same time, there’s manifest evidence out there that probiotics do have an impact on intestinal and immune health.”
He predicted a probiotic claim would be authorised within 12 months, a development EFSA’s health claim panel chief, professor Ambroise Martin, has himself acknowledged.
Also working on the double-blind, randomised, placebo-controlled study were researchers from Comenius University and the Juvenalia Paediatric Centre in Slovakia and the Imperial College London.
Source: European Journal of Clinical Nutrition
Published online ahead of print, doi:10.1038/ecjn.2014.174
‘Probiotics and vitamin C for the prevention of respiratory tract infections in children attending preschool: a randomised controlled pilot study’
Authors: I. Garaiova, J. Muchova, Z. Nagyova, D. Wang, J.V. Li, Z. Orszaghova, D.R. Michael, S.F. Plummer, Z. Durackova