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

Sponsors and Collaborators:	National University Hospital, Singapore National University, Singapore
Information provided by:	National University Hospital, Singapore
ClinicalTrials.gov Identifier:	NCT00365469

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 II

MedlinePlus related topics: Asthma Dietary Supplements Eczema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Caregiver), Placebo Control, Parallel Assignment, Efficacy Study
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

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

Primary Outcome Measures:

Asthma [ Time Frame: 5 years of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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
Probiotic: Experimental 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: Placebo Comparator 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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365469

Locations

Singapore
National University Hospital
Singapore, Singapore, 119074

Sponsors and Collaborators

National University Hospital, Singapore

National University, Singapore

Investigators

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:	National University Hospital, Singapore ( Dr Marion Aw, Consultant )
Study ID Numbers:	SQNU01 (Phase II)
Study First Received:	August 16, 2006
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00365469 History of Changes
Health Authority:	Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:

Probiotics
Eczema
Asthma

Allergic Rhinitis
Prevention
Immunological responses

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Bronchial Diseases
Skin Diseases
Asthma
Rhinitis
Eczema
Lung Diseases, Obstructive
Hypersensitivity

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Sulfalene
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Respiratory Hypersensitivity
Dermatitis

Additional relevant MeSH terms:

Otorhinolaryngologic Diseases
Bronchial Diseases
Immune System Diseases
Skin Diseases
Asthma
Rhinitis
Eczema
Nose Diseases
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Respiratory Hypersensitivity
Dermatitis

ClinicalTrials.gov processed this record on May 06, 2009