Respiratory tract infections in children Respiratory Respiratory tract infections
Conditions
Interventions
Participants randomised to active or placebo group will be required to take one chewable tablet per day for 6 months.
1. Active intervention: Probiotics consisting of a combination of 4 strains
L. acidophilus CUL-60, L. acidophilus CUL-21, B. bifidum CUL-20 and B. lactis CUL-34 at a total of 1.25x10^10 cfu per tablet and 50 mg vitamin C and xylitol (base ingredient) per tablet
2. Placebo:
Sponsors
Cultech Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 4 to 6 years old of either sex 2. Parental/guardian written informed consent and completed confidential health status to be obtained for all children participating
Exclusion criteria
Exclusion criteria: 1. Participants whose parents are unable/unwilling to give written informed consent 2. Participants who are not prepared to provide blood, urine and saliva samples as required 3. Participants who are taking the products/medications for the stimulation of immune system (â glucans), isoprinosine (methisoprinolum), ribomunyl, immunomodulants (lysate of bacteria) 4. Participants who are taking regularly daily any dairy probiotic product (yoghurt with biocultures, Acidophilus milk, kefir, etc), probiotic supplements 5. Participants sensitive to xylitol/sorbitol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, duration and severity of upper and lower respiratory tract infections and gastrointestinal infections. Symptom Diary is collected on weekly basis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in key immunological parameters and markers of oxidative stress 2. Changes in levels of sIgA and cortisol Blood, saliva and urine samples are collected at baseline and 6 months. | — |
Countries
Slovakia
Outcome results
None listed