ProVen:

Probiotics for Childhood Allergies, Coughs & Colds

Webinar 12

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Antibiotics In Early Life And Risk Of Childhood AllergyEczemaPostnatal ( 2 week post birth) antibiotic exposure was associated with a 40% increased risk of eczema, with further 7% increasedrisk for each additional antibiotic course received during the first year of life (OR= 1.41, 95%CI: 1.30, 1.53)

Asthma Meta-analysis of 20 studies found that exposure to antibiotic in the first year of life increases the risk of developing childhood asthma by 50% (OR= 1.52, 95%CI: 1.30, 1.77) 22% children born to mothers who took antibiotics during pregnancy were diagnosed with asthma by age 3 compared to 11% children born to mothers who didn’t take antibiotics (P<0.01).

Rhinitis Antibiotics in the first week of life increased the risk of allergic rhinitis at 8 years old school children by 75% (aOR= 1.75, 95%CI: 1.03, 2.97)

(Tsakok T et al, Br J Dermatol 2013; Alm B et al, Pediatr Allergy Immunol 2014) (Murk W et al, Pediatrics 2011) (Lapin B et al, Ann Allergy Asth Immunol 2015)

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( Vangay P et al, Cell Host & Microbe 2015, Pelucchi C et al, Epidemiology 2012)

Probiotics in the Prevention of Childhood Allergy

• Type 1 hypersensitivity effects approximately 20% of children

• Almost all allergy established in first 2 years of life

• First expression is atopic eczema, followed by asthma, and rhinitis – the ‘allergic march’

• Meta analyses of 11 infant studies shows average of 20% reduction of IgE related eczema

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Swansea Baby Study - Allergy Prevention Trial

AIM

Investigate the effect of probiotics on prevention of allergic sensitization and allergic eczema in infants

STUDY DESIGN:

DBPC study with 454 mother-infant pairs

ProVen Pregnancy provided to mothers in 3rd trimester and

ProVen Baby provided to babies daily from birth for 6 months

Follow up: 6 months and 2 years Allen SJ et al Arch Dis Child 2014, 99: 1014-1019

Allen SJ et al J Nutr 2010, 140: 483-88

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Atopic eczema in infant

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PROBAT STUDY: PROBIOTICS IN PREVENTION OF ALLERGY

Allen SJ et al. Archives of Disease in Childhood 2014 Jun 19; doi:10.1136/archdischild-2013-305799

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Swansea Study Demonstrated Safety Of ProVen Probiotics in Mothers and in Newborns

ProVen Pregnancy and ProVen Baby administration was not associated with adverse events in either mothers or their infants.

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Swansea Baby Trial – Clinical OutcomesSignificant Reduction in Atopic Sensitisation in Children of 6 and 24 Months

Atopic sensitisation measured by skin prick test reaction to one or more of following allergens:cows milk, egg, grass pollen, tree pollen, house dust mite, nuts, fish.

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Result: The Effect of Lab4b Probiotics on Incidence of Atopic Eczema at 6 and 24

Months From Birth Atopic eczema defined as SCORAD measurement of skin rash co presented with SPT positivity for at least one allergen.

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Result: 57% reduction of risk of atopic eczema in ProVen Baby group!!

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Coughs and Colds – we all get ‘em! Coughs and colds – or upper respiratory tract infections ( UTRI) – are the most common infections we experience –adults 2-3 episodes per year: children 3-8 episodes per year.

No really effective treatment:No consistent evidence of prevention – until now!!Recent meta- analysis 20 trials concluded that ‘…probiotics reduce duration of infection by average of 30%’ King et al 2014

Symptoms:• sore throat• runny or blocked nose• cough• sneezing

Most common cause of:• days off work• absenteeism from school• visits to doctor• antibiotic use ( despite no

effect)

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Are Probiotics More Effective Than Vitamin C and Zinc in Prevention of Coughs and Colds

Recent Cochrane meta-analysis concluded that vitamin C at doses above 200mg/day:- reduced duration of coughs and colds in adults by average of 8% - reduced duration of coughs and colds in children by 14% ( 18% when 1-2g/day taken)

Hermila 2013 Cochrane ReportRecent meta-analysis for zinc concluded:

- no effect in prevention of coughs and colds- some effect in reduction of duration when taken within 24 hours of symptom onset.

Singh 2013 Cochrane Report

King 2014 in meta-analysis of 20 trials in adults and children concluded that probiotics reduce the duration of cough and cold symptoms by 30%!

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AIM:

To assess the impact of the combination of LAB4 probiotics with vitamin C on upper respiratory tract infections in children attending preschool facilities.

STUDY DESIGN:

Randomised double blind placebo controlled study : 57 children aged between 4-6 years provided with ProVen Fit for School daily for 6 months during the autumn and winter.

PROCHILD Study

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PROCHILD STUDY: Probiotics in the prevention of coughs and colds

Garaiova I et al. European Journal of Clinical Nutrition 2014 Sept 10; doi:10.1038/ejcn.2014.174

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PROCHILD Study – Main Results

• Total number of days with URTI symptoms (sneezing, sore throat, cough, runny/blocked nose

51% reduction in active group (p= 0.0059)

• Frequency of occurrence of URTI symptoms

33% reduction in active group (p= 0.0019)

• Absence from preschool

30% reduction in active group (p= 0.0069)

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Sneezing Runny nose Blocked nose Sore throat Cough Total URTIsymptoms

Total Number of Days with URTI Symptoms

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P = 0.07

Reduces Duration of UTRI Symptoms by 50%

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Reduces Incidence of URTI Symptoms by 33%

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Due to URTI Any Illness

Total Number of Days Absent from Preschool Facilities

Placebo Lab4+Vitamin C

P = 0.007 P=0.0069

Reduces Absenteeism from School by 30%

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Cough medicine Antihistamins Nasal spray/drops Painkillers Total

Total Number of Days of Medication Usage

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Total Medication Reduced by 50%

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Due to URTI Any Illness

Total Number of Physician Visits

Placebo Lab4+Vitamin C

P = 0.08

Visits to Physician Reduced by 50%

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Number of children (%)

24.114.3

NUMBER OF CHILDREN WITH A LEAST ONE DAY OF ORAL

ANTIBIOTIC USEPlacebo Lab4+Vitamin C

Reduce Antibiotic Use by 40%

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The Gut-Brain Axis