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

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ClinicalTrials.gov Identifier: NCT00365469
Recruitment Status : Completed
First Posted : August 17, 2006
Last Update Posted : January 9, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Eczema Asthma Allergic Rhinitis Dietary Supplement: Probiotic Other: Placebo Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
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
Study Start Date : May 2006
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Asthma [ Time Frame: 5 years of age ]

Secondary Outcome Measures :
  1. Atopic eczema [ Time Frame: 5 years of age ]
  2. Allergic Rhinitis [ Time Frame: 5 years of age ]
  3. Allergen sensitization [ Time Frame: 5 years of age ]
  4. Food Allergy [ Time Frame: 5 years of age ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Paediatrics, Dr Marion Aw, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00365469     History of Changes
Other Study ID Numbers: SQNU01 (Phase II)
First Posted: August 17, 2006    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014

Keywords provided by Paediatrics, National University Hospital, Singapore:
Probiotics
Eczema
Asthma
Allergic Rhinitis
Prevention
Immunological responses

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Eczema
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dermatitis
Skin Diseases
Skin Diseases, Eczematous