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

This study has been completed.
Sponsor:
Collaborators:
National Medical Research Council (NMRC), Singapore
National University, Singapore
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00318695
First received: April 26, 2006
Last updated: January 21, 2009
Last verified: January 2009
History of Changes
  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
 Dietary Supplement: Probiotics
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Influence of Probiotics on Prevention of Atopy, Atopic Disease and Immunological Responses- A Randomized Double-Blind Placebo Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

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

Enrollment: 253
Study Start Date: May 2004
Study Completion Date: January 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotics
Bifidobacterium longum [BL999] and Lactobacillus rhamnosus [LPR]
 Dietary Supplement: Probiotics
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:

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

No publications provided

ClinicalTrials.gov Identifier: NCT00318695     History of Changes
Other Study ID Numbers: SQNU01
Study First Received: April 26, 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 May 19, 2013