None listed
Conditions
Brief summary
Respiratory tract infections in children under the age of 5 years are common and are a major cause of hospitalisation and even death. More minor respiratory tract infections such as colds and flus often result in children being unable to attend childcare due to the illness, and their parents therefore being unable to attend work in order to care for them. The bacteria that reside in the human gut play an important role in immunity. However, when the gut bacteria are out of natural balance, health and immunity can be compromised. Probiotic supplementation is one way in which the composition of the gut microbiota can be restored. Probiotics are live micro-organisms that have been shown to reduce the incidence, duration, and severity of viral and cold and flu like illnesses in children. This study will conduct a randomised, double-blind, placebo controlled trial to test whether a probiotic can reduce the number of days children have symptoms of cold and flu-like illnesses.
Interventions
Participants who are randomly assigned to the intervention group will receive capsules containing the probiotic Bifidobacterium animalis HN019 (6X109 colony forming units).
Since the participants are children aged 1-5 years, the tablets are recommended to be broken open and the powder sprinkled into food or drinks.
Participants will be instructed to take one capsule a day for a period of 10 weeks.
Adherence will be assessed by asking participants to enter the number of remaining capsules th
Participants who are randomly assigned to the intervention group will receive capsules containing the probiotic Bifidobacterium animalis HN019 (6X109 colony forming units). Since the participants are children aged 1-5 years, the tablets are recommended to be broken open and the powder sprinkled into food or drinks. Participants will be instructed to take one capsule a day for a period of 10 weeks. Adherence will be assessed by asking participants to enter the number of remaining capsules they have in the bottle at the post-intervention data collection phase
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
12 Months to 5 Years
Healthy volunteers
Yes
Inclusion criteria
Children will be eligible to participate in the study if they • Are aged between 12 months and less than 5 years at the time of enrolment • Attend childcare regularly 2 sessions/week or more • Have not had antibiotics in the last two weeks • Do not have a sibling enrolled in the study • Are not on immune suppressant therapy
Exclusion criteria
None
Outcome results
None listed