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

This study has been completed.
Sponsor:
Collaborator:
National University, Singapore
Information provided by (Responsible Party):
Paediatrics, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00365469
First received: August 16, 2006
Last updated: January 7, 2014
Last verified: January 2014

August 16, 2006
January 7, 2014
May 2006
September 2011   (final data collection date for primary outcome measure)
Asthma [ Time Frame: 5 years of age ] [ Designated as safety issue: No ]
Asthma by 5 years of age
Complete list of historical versions of study NCT00365469 on ClinicalTrials.gov Archive Site
  • Atopic eczema [ Time Frame: 5 years of age ] [ Designated as safety issue: No ]
  • Allergic Rhinitis [ Time Frame: 5 years of age ] [ Designated as safety issue: No ]
  • Allergen sensitization [ Time Frame: 5 years of age ] [ Designated as safety issue: No ]
  • Food Allergy [ Time Frame: 5 years of age ] [ Designated as safety issue: No ]
  • Atopic eczema by 5 years of age
  • Allergic Rhinitis by 5 years of age
  • Allergen sensitization by 5 years of age
  • Food Allergy by 5 years of age
Not Provided
Not Provided
 
Influence of Probiotics on Atopy, Immunological Responses and Gut Microflora - Follow-up to 5 Years
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
  • Eczema
  • Asthma
  • Allergic Rhinitis
  • Dietary Supplement: Probiotic
    Bifidobacterium longum [BL999] and Lactobacillus rhamnosus [LPR]
  • Other: Placebo
    Commercially available cow's milk based infant formula without probiotic supplementation
  • Experimental: Probiotic
    Commercially available cow's milk based infant formula with Bifidobacterium longum [BL999} and Lactobacillus rhamnosus [LPR]
    Intervention: Dietary Supplement: Probiotic
  • Placebo Comparator: Placebo
    Commercially available cow's milk based infant formula without probiotic supplementation
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
253
September 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00365469
SQNU01 (Phase II)
Yes
Paediatrics, National University Hospital, Singapore
National University Hospital, Singapore
National University, Singapore
Principal Investigator: Dr Marion Aw, Consultant National University Hospital, Singapore
Principal Investigator: Dr Lynette Shek, Consultant National University Hospital, Singapore
National University Hospital, Singapore
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP