PROCHILD: Probiotics in prevention of respiratory tract infections

Completed

• Conditions: Respiratory tract infections in children; Respiratory tract infections; Respiratory

• Registration Number: ISRCTN28722693
• Lead Sponsor: Cultech Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-08
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence, duration and severity of upper and lower respiratory tract infections and gastrointestinal infections.<br>Symptom Diary is collected on weekly basis.

Secondary Outcome Measures

Name	Time	Method
1. Changes in key immunological parameters and markers of oxidative stress<br>2. Changes in levels of sIgA and cortisol<br>Blood, saliva and urine samples are collected at baseline and 6 months.