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

Asthma Clinical Trial

Official title:

Influence of Probiotics on Prevention of Atopy, Atopic Disease and Immunological Responses- A Randomized Double-Blind Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318695
• Other study ID #: SQNU01
• Status: Completed
• Phase: Phase 2
• First received: April 26, 2006
• Last updated: January 21, 2009
• Start date: May 2004
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: January 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Eczema

Intervention

Dietary Supplement:
• Probiotics
Bifidobacterium longum [BL999] and Lactobacillus rhamnosus [LPR]

Other:
• Placebo
Commercially available cow's milk based infant formula without probiotic supplementation

Locations

Country	Name	City	State
Singapore	National University Hospital (NUH)	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National Medical Research Council (NMRC), Singapore, National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atopic eczema by 2 years of age
Secondary	Asthma by 2 years of age
Secondary	Allergic Rhinitis by 2 years of age
Secondary	Allergen sensitization by 2 years of age