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Completed

NCT Number: NCT00365469

Influence of Probiotics on Atopy, Immunological Responses and Gut Microflora - Follow-up to 5 Years

The investigators had conducted a double-blind, randomized placebo-controlled clinical trial studying the effects of 6 months probiotics supplementation from birth on allergic disease and sensitization up to 2 years of age. This follow-up study will extend a further 3 years to 5 years of age for assessing the longer term beneficial effects of this form of probiotics intervention on the incidence of allergic disease and sensitization at 5 years of age.

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Key information

About this study

Probiotics are helpful bacteria of healthy gut and have shown potential in reducing allergy. A double-blind, randomized placebo-controlled clinical trial studying the effects of 6 months probiotics supplementation from birth on allergic disease and sensitization up to 2 years of age had been conducted. This study aims to assess the longer term beneficial effects of this form of intervention on the incidence of allergic disease and sensitization at 5 years of age by extending the follow-up period.

All children (from original cohort of 253) who completed the initial 2-year visit has been invited to participate. They will be evaluated with monthly phone calls and yearly clinic visits. Allergic sensitization will be assessed with skin prick tests to a panel of allergens.

This project will provide insights into the role of early supplementation of probiotics on the development of the immune system and its effect on allergy. The additional follow-up period is critical for the evaluation of respiratory allergies in the form of clinical asthma, allergic rhinitis and sensitization to inhalant allergens, which tend to develop after 2 years of age.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parents agree to the subject's participation in the study and informed consent has been obtained.
  • The subject has been a participant in the Phase I double-blind, randomized placebo-controlled study and had taken either normal infant formula or formula supplemented with probiotics postnatally for 6 months.
  • The parents are willing to comply with study procedures and are able to keep to scheduled clinic visits.

Exclusion criteria

  • The parent is unable /unwilling to comply with procedures.

Treatment and study plan

Probiotic

Dietary Supplement

Bifidobacterium longum [BL999] and Lactobacillus rhamnosus [LPR]

Placebo

Other

Commercially available cow's milk based infant formula without probiotic supplementation

Primary outcomes

  1. Asthma

    Time frame: 5 years of age

Secondary outcomes

  1. Atopic eczema

    Time frame: 5 years of age

  2. Allergic Rhinitis

    Time frame: 5 years of age

  3. Allergen sensitization

    Time frame: 5 years of age

  4. Food Allergy

    Time frame: 5 years of age

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • National University of Singapore

Registry information

Official study title

A Follow-up Study to 5 Years of a Randomized, Double-blinded, Placebo-controlled Study on the Influence of Probiotics on Atopy, Immunological Responses and Gut Microflora

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Aug 17, 2006
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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