Probiotics and the Prevention of Allergic Disease:

1
Probiotics and the Prevention of Allergic
Disease Treatment Compliance at Twelve
Months B Jones1, K Wickens1, A Nicholson1, S
Molloy1, P Lampshire1, T Stanley1, P Black2, E
Mitchell2, P Fitzharris2, J Crane. Acknowledgemen
t Dr Tristram Ingham1 Funding Health Research
Council of NZ and Fonterra. 1 Wellington School
of Medicine and Health Sciences, University of
Otago 2 The University of Auckland Faculty of
Medical and Health Sciences
2
Introduction

• Previous studies suggest probiotics during
  infancy may protect against the development of
  allergic dermatitis in the first two years of
  life.
• The study from birth to two years is a double
  blind randomised controlled trial of the effects
  of Lactobacillus Rhamnosus and Bifidobacteria
  Lactis on atopy and eczema.
• The success of the study depends on good subject
  compliance.

3
Aim

• The aim of this analysis is to determine the
  compliance of the participants in the Wellington
  area during the first twelve months.

4
Methods

• Infants with a family history of allergic disease
  were enrolled through midwifery services.
• Research nurses visited within a week of the
  childs birth to demonstrate the daily
  administration of the powder using the placebo.
• The powder from the capsules was mixed with
  breast milk, water or formula, then administered
  by syringe or teaspoon, or by direct application
  to the tongue prior.
• Every three months capsules were replaced and
  remaining capsules counted.
• Compliance was calculated as the number of
  capsules taken as a proportion of the total days
  covered.
• We define good compliance as compliance gt80.

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Babies at 12 Months

• Birth (Eligible) 238
• Withdrawn (From study)11
• Inactive (Not taking capsules) 10
• Total Active (Taking capsules) 217

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Results
ComplianceLevel
ComplianceLevel
7
Compliance at 12 Months
(n 217)
ComplianceLevel
8
gt80 Compliance

• During the first 12 months 74.5 of the
  participants had taken over 80 of their
  capsules.

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Odds Ratios (95 CI) Showing Associations of
Selected Factors With Compliance
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Associations of Selected Factors with Compliance

• Homes with an only child had a slightly better
  chance in achieving gt80 compliance than those
  with 1 or more other children.
• Households with an income greater than 60,000
  were more than twice as likely to have good
  compliance than those with incomes less than
  60,000.
• Households in which mothers had had over 5 years
  post-primary education were less than half as
  likely to achieve good compliance as those with
  mothers with 2-5 years Post-Primary education.

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Discussion

• Administering the powder to the babies was a
  major challenge for
• many of the mothers. Some of the factors that
  contributed to this
• were breastfeeding difficulties, post-natal
  depression, maternal
• illness, sleep deprivation and child illness.
• The capsules required constant refrigeration
  which was difficult for
• families moving house, going on holiday or
  travelling overseas.
• Increased awareness of the possible benefits of
  probiotics saw some
• health professionals prescribe other probiotics
  to the babies or
• recommend babies stop taking the powder.
• The researcher/parent relationship was essential
  to the continued
• good compliance during this 12 month period.

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Conclusions

• Overall the mothers have shown excellent
  compliance in giving the capsules to their
  babies.
• Compliance improved after the first 3 months when
  babies started on solid food.
• There is greater compliance in higher income
  households but lower compliance with mothers with
  higher education.
• With nearly 75 of mothers achieving gt 80
  compliance the study is well placed to report on
  the effects of probiotics and the development of
  allergic disease in children.