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

National University Health System (NUHS)

Status and phase: Completed; Phase 2

Conditions: Asthma; Allergic Rhinitis; Eczema

Treatments: Dietary Supplement: Probiotic; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00365469

SQNU01 (Phase II)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 253 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

253 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo