Influence of Probiotics on Prevention of Atopy, Atopic Disease and Immunological Responses

NCT00318695 | Completed Phase 2 DMC

• 1 other identifier: SQNU01
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eczema; Asthma; Allergic Rhinitis

Keywords

Probiotics; Eczema; Asthma; Allergic Rhinitis; Prevention; Immunological responses

Outcome Measures

Primary Outcomes (1)

• Atopic eczema by 2 years of age

Secondary Outcomes (3)

• Asthma by 2 years of age

• Allergic Rhinitis by 2 years of age

• Allergen sensitization by 2 years of age

Study Arms (2)

Probiotics

EXPERIMENTAL

Bifidobacterium longum \[BL999\] and Lactobacillus rhamnosus \[LPR\]

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

Commercially available cow's milk based infant formula without probiotic supplementation

Other: Placebo

Interventions

Probiotics DIETARY_SUPPLEMENT

Bifidobacterium longum \[BL999\] and Lactobacillus rhamnosus \[LPR\]

Probiotics

Placebo OTHER

Commercially available cow's milk based infant formula without probiotic supplementation

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National Medical Research Council (NMRC), Singapore: collaborator
• National University of Singapore: collaborator

Study Sites (1)

National University Hospital (NUH)

Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Eczema; Asthma; Rhinitis, Allergic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dr Lynette Shek, Consultant

  National University Hospital (NUH), Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 26, 2006
• First Posted: April 27, 2006
• Study Start: May 1, 2004
• Primary Completion: July 1, 2008
• Study Completion: January 1, 2009
• Last Updated: January 22, 2009

Record last verified: 2009-01

Locations

SG (1)