Effect of Lactobacillus rhamnosus on the incidence of URTI in children
Research type
Research Study
Full title
The effect of Lactobacillus rhamnosus ATCC 53103 on the defence against pathogens in the upper respiratory tract in healthy children – a single-center, randomized, double-blind, placebo-controlled study with 16 weeks intervention.
IRAS ID
247999
Contact name
Mette Keller
Contact email
Sponsor organisation
Chr Hansen
Duration of Study in the UK
0 years, 5 months, 29 days
Research summary
The study is a randomized, placebo controlled, double blinded, two armed trial in children aged 2-6 years. Our target number is 700 in the study, but 900 to be screened. The trial will investigate the effect of Lactobacillus rhamnosus ATCC 53103 on incidence and duration of URTI over a period of 4 months.
Recruitment will be through social media.
After information about the trial to the guardians, the children will be enrolled in the study and receive a baseline examination by GP. After randomization they will receive either test product (probiotic) or placebo and instructions for intake. They will receive information about symptoms of URTI and be encouraged to see a study GP when symptoms present during the study period. Each day they will receive a text, asking if the child has any symptoms and to confirm intake of study product.
In case of symptoms, they will receive a link to a questionnaire about the symptoms and be asked to see an assigned study-GP. The GP will make a diagnosis based on a structured clinical examination, a validated questionnaire and confirm it by nasal swab samples.
During the study period the families will receive a phone call a month to encourage compliance.
This study is a food study and the study product is not an IMP or a medical device.REC name
East of Scotland Research Ethics Service REC 2
REC reference
18/ES/0087
Date of REC Opinion
28 Aug 2018
REC opinion
Further Information Favourable Opinion