Influence of Probiotics on Atopy, Immunological Responses and Gut Microflora - Follow-up to 5 Years
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Eczema Asthma Allergic Rhinitis |
Dietary Supplement: Probiotic Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Prevention |
| Official 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 |
- Asthma [ Time Frame: 5 years of age ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 253 |
| Study Start Date: | May 2006 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Probiotic
Commercially available cow's milk based infant formula with Bifidobacterium longum [BL999} and Lactobacillus rhamnosus [LPR]
|
Dietary Supplement: Probiotic
Bifidobacterium longum [BL999] and Lactobacillus rhamnosus [LPR]
|
|
Placebo Comparator: Placebo
Commercially available cow's milk based infant formula without probiotic supplementation
|
Other: Placebo
Commercially available cow's milk based infant formula without probiotic supplementation
|
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Singapore | |
| National University Hospital | |
| Singapore, Singapore, 119074 | |
| Principal Investigator: | Dr Marion Aw, Consultant | National University Hospital, Singapore |
| Principal Investigator: | Dr Lynette Shek, Consultant | National University Hospital, Singapore |
More Information
No publications provided
| Responsible Party: | Dr Marion Aw, Consultant, National University Hospital, Singapore |
| ClinicalTrials.gov Identifier: | NCT00365469 History of Changes |
| Other Study ID Numbers: | SQNU01 (Phase II) |
| Study First Received: | August 16, 2006 |
| Last Updated: | January 21, 2009 |
| Health Authority: | Singapore: Domain Specific Review Boards |
Keywords provided by National University Hospital, Singapore:
|
Probiotics Eczema Asthma |
Allergic Rhinitis Prevention Immunological responses |
Additional relevant MeSH terms:
|
Asthma Eczema Rhinitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Dermatitis Skin Diseases Skin Diseases, Eczematous Nose Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013