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

This study has been completed.
Sponsor:
Collaborator:
National University, Singapore
Information provided by (Responsible Party):
Paediatrics, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00826189
First received: January 21, 2009
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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
Asthma
Allergic Rhinitis

Study Type: Observational
Study Design: 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

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Asthma [ Time Frame: 7 years of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Allergic Rhinitis [ Time Frame: 7 years of age ] [ Designated as safety issue: No ]

Enrollment: 253
Study Start Date: May 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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".

  Eligibility

Ages Eligible for Study:   5 Years to 7 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826189

Locations
Singapore
National University Hospital, Singapore
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
National University, Singapore
Investigators
Principal Investigator: Lynette Shek, A/Prof National University Hospital, Singapore
Principal Investigator: Marion Aw, A/Prof National University Hospital, Singapore
  More Information

No publications provided

Responsible Party: Paediatrics, A/Prof Lynette Shek, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00826189     History of Changes
Other Study ID Numbers: SQNU01 (Phase III)
Study First Received: January 21, 2009
Last Updated: January 8, 2014
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
Probiotics
Asthma
Allergic Rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 27, 2014