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

NCT00365469 | Completed Phase 2 DMC

• 1 other identifier: SQNU01 (Phase II)
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eczema; Asthma; Allergic Rhinitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Asthma

  5 years of age

Secondary Outcomes (4)

• Atopic eczema

  5 years of age

• Allergic Rhinitis

  5 years of age

• Allergen sensitization

  5 years of age

• Food Allergy

  5 years of age

Study Arms (2)

Probiotic

EXPERIMENTAL

Commercially available cow's milk based infant formula with Bifidobacterium longum \[BL999} and Lactobacillus rhamnosus \[LPR\]

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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

Probiotic

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.
• 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.

You may not qualify if:

• The parent is unable /unwilling to comply with procedures.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

National University Hospital

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 Marion Aw, Consultant

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

• Dr Lynette Shek, Consultant

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Marion Aw

Study Record Dates

• First Submitted: August 16, 2006
• First Posted: August 17, 2006
• Study Start: May 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 9, 2014

Record last verified: 2014-01

Locations

SG (1)