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Influence of Probiotics on Atopy With Focus on Respiratory Allergic Diseases- Follow-up to 7 Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00826189
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : January 9, 2014
National University, Singapore
Information provided by (Responsible Party):
Paediatrics, National University Hospital, Singapore

Brief Summary:

The investigators had conducted an initial double-blind, placebo-controlled clinical trial (NCT00318695) to study the effects of probiotic supplementation from birth to 6 months of age in the incidence of atopic diseases at 2 years old. This is then further investigated up to 5 years of age in a follow-up study NCT00365469 to assess the longer term beneficial effects.

This current study intends to follow-up for another 2 years until 7 years of age as this is critical in the evaluation of respiratory allergies in the form of clinical asthma and allergic rhinitis.

Condition or disease
Asthma Allergic Rhinitis

Detailed Description:

This study intends to continue the initial double-blind, placebo-controlled randomized clinical trial (NCT00318695) which involved 253 subjects with a first degree family history of allergic disease. The infants received at least 60ml of commercially available cow's milk based infant formula with or without probiotic supplementation (Bifidobacterium longum [BL999] 1×10*7 colony-forming unit (cfu)/g and Lactobacillus rhamnosus [LPR]2×10*7 cfu/g) daily from the first day of life for the first 6 months. A follow-up study (NCT00365469) up to 5 years of age is currently in process.

This current study plans to continue the follow-up for a further 2 years till the cohort reaches 7 years of age. This study will only involve telephone calls which will be conducted every 3 months to ascertain for symptoms and incidence of respiratory allergic disease.This is critical in the evaluation of asthma and allergic rhinitis which tend to develop later in life and this step-wise, temporal development of respiratory allergies has been described as "Atopic March".

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Study Type : Observational
Actual Enrollment : 253 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Follow-up Study to 7 Years of a Randomized, Double-blinded, Placebo-controlled Study on the Influence of Probiotics on Atopy With Focus on Respiratory Allergic Diseases
Study Start Date : May 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Primary Outcome Measures :
  1. Asthma [ Time Frame: 7 years of age ]

Secondary Outcome Measures :
  1. Allergic Rhinitis [ Time Frame: 7 years of age ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The subjects who have completed NCT00318695 and NCT00365469 studies will be invited to participate in this study.

Inclusion Criteria:

  • Subject has completed the both NCT00318695 and NCT00365469 studies.
  • Parent(s) / Guardian consent to the subject's participation in the study.
  • Subject and the parent(s)/ guardian are willing to comply with the study procedures

Exclusion Criteria:

  • The parent is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained.
  • The parent is unable/ unwilling to comply with study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00826189

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National University Hospital, Singapore
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
National University, Singapore
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Principal Investigator: Lynette Shek, A/Prof National University Hospital, Singapore
Principal Investigator: Marion Aw, A/Prof National University Hospital, Singapore
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Responsible Party: Paediatrics, A/Prof Lynette Shek, National University Hospital, Singapore Identifier: NCT00826189    
Other Study ID Numbers: SQNU01 (Phase III)
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014
Keywords provided by Paediatrics, National University Hospital, Singapore:
Allergic Rhinitis
Additional relevant MeSH terms:
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Rhinitis, Allergic
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases