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

This study has been completed.
Sponsor:
Collaborator:
National University, Singapore
Information provided by (Responsible Party):
Paediatrics, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00365469
First received: August 16, 2006
Last updated: January 7, 2014
Last verified: January 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
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

Resource links provided by NLM:


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 ]

Enrollment: 253
Study Start Date: May 2006
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic
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 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:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Paediatrics, Dr Marion Aw, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00365469     History of Changes
Other Study ID Numbers: SQNU01 (Phase II)
Study First Received: August 16, 2006
Last Updated: January 7, 2014
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:
Rhinitis
Rhinitis, Allergic, Perennial
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 20, 2014