Influence of Probiotics on Atopy With Focus on Respiratory Allergic Diseases- Follow-up to 7 Years
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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 |
- Asthma [ Time Frame: 7 years of age ] [ Designated as safety issue: No ]
- Allergic Rhinitis [ Time Frame: 7 years of age ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 253 |
| Study Start Date: | May 2009 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
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 |
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
Contacts and Locations| Contact: Lynette Shek, A/Prof | 65-67724420 | paeshekl@nuhs.edu.sg |
| Contact: Marion Aw, A/Prof | 65-67724420 | paeawm@nuhs.edu.sg |
| Singapore | |
| National University Hospital, Singapore | |
| Singapore, Singapore, 119074 | |
| 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: | A/Prof Lynette Shek, National University of Singapore and National University Hospital |
| ClinicalTrials.gov Identifier: | NCT00826189 History of Changes |
| Other Study ID Numbers: | SQNU01 (Phase III) |
| Study First Received: | January 21, 2009 |
| Last Updated: | January 21, 2009 |
| Health Authority: | Singapore: Domain Specific Review Boards |
Keywords provided by National University Hospital, Singapore:
|
Probiotics Asthma Allergic Rhinitis |
Additional relevant MeSH terms:
|
Asthma Rhinitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Nose Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013