Influence of Probiotics on Prevention of Atopy, Atopic Disease and Immunological Responses - Full Text View

Purpose

This will be a double-blind, randomized placebo-controlled study. 253 children were recruited and randomly assigned into one of 2 groups to receive either normal infant formula or formula with Bifidobacterium longum and Lactobacillus rhamnosus GG. The primary aim is to assess the effect of early administration (from birth) of probiotics on the incidence of allergic sensitization, eczema, asthma and rhinitis.

Condition	Intervention	Phase
Eczema Asthma Allergic Rhinitis	Drug: Bifidobacterium longum Drug: Lactobacillus rhamnosus GG	Phase II

MedlinePlus related topics:

Asthma Eczema

ChemIDplus related topics:

Sulfalene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Influence of Probiotics on Prevention of Atopy, Atopic Disease and Immunological Responses- A Randomized Double-Blind Placebo Controlled Trial

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

Primary Outcome Measures:

Atopic eczema by 2 years of age

Secondary Outcome Measures:

Asthma by 2 years of age
Allergic Rhinitis by 2 years of age
Allergen sensitization by 2 years of age

Estimated Enrollment:	253
Study Start Date:	May 2004

Detailed Description:

One of the most important early influences on the immune system is the intestinal microflora. The gastrointestinal tract, being the largest body area interacting with the environment, is one of the earliest to be colonized and is quantitatively the most important source of microbial stimulation for the immature immune system. Probiotics are helpful bacteria from healthy intestinal tract, and have shown potential in reducing allergy. This is extremely important as allergic diseases are on the rise worldwide. Probiotics are safe, easy to administer and can be used early for intervention as allergic sensitization, once established, is difficult to reverse.

This double-blind, randomized placebo-controlled study has recruited 253 children from birth. These babies, with a family history of atopic disease, will be randomly assigned into one of 2 groups to receive either normal infant formula or formula with Bifidobacterium longum and Lactobacillus rhamnosus GG. The formula will be consumed postnatally for 6 months, after which the child will continue with normal follow-on milk. Children will be examined at the neonatal period and at 1, 3, 6, 12 and 24 months. Blood samples will be collected at birth (cord blood) and at 1 year of age. Blood will be analyzed for cytokines, total IgE and specific IgE. Skin prick test for common allergens will also be performed at 1 year of age. Stools will be collected at 5 days, 1, 3, 12 months and analyzed for the pattern of stool colonization.

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.
Either parent or sibling (i.e. first degree relative) has a history of atopy. This will be evidenced by a doctor-diagnosis of asthma, allergic rhinitis or eczema and a positive skin prick test to any of a panel of common allergens.
The subject is born at above 35 weeks of gestation and weighs above 2 kg.
The subject does not have major congenital malformations/major illness.
Family appears to be able to successfully complete this trial.

Exclusion Criteria:

Mother has a medical illness, which in the opinion of the investigator, will interfere with the results of the study.
The parent is unable/unwilling to comply with procedures.
The parents choose to totally breast-feed the child.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318695

Locations


Singapore
	National University Hospital (NUH)
	Singapore, Singapore, 119074

Sponsors and Collaborators

National University Hospital, Singapore

National Medical Research Council (NMRC), Singapore

National University, Singapore

Investigators


Principal Investigator:	Dr Lynette Shek, Consultant	National University Hospital (NUH), Singapore

More Information

Study ID Numbers:	SQNU01
First Received:	April 26, 2006
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00318695
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

Skin Diseases

Asthma

Rhinitis

Eczema

Lung Diseases, Obstructive

Hypersensitivity

Respiratory Tract Diseases

Respiratory Tract Infections

Lung Diseases

Sulfalene

Hypersensitivity, Immediate

Skin Diseases, Eczematous

Respiratory Hypersensitivity

Dermatitis

Additional relevant MeSH terms:

Immune System Diseases

Bronchial Diseases

Nose Diseases

ClinicalTrials.gov processed this record on October 06, 2008

Sponsors and Collaborators:	National University Hospital, Singapore National Medical Research Council (NMRC), Singapore National University, Singapore
Information provided by:	National University Hospital, Singapore
ClinicalTrials.gov Identifier:	NCT00318695