Contact information
Type
Scientific
Primary contact
Prof Zdenka Durackova
ORCID ID
Contact details
Institute of Medical Chemistry
Biochemistry and Clinical Biochemistry
Medical School
Comenius University
Sasinkova 2
Bratislava
813 72
Slovakia
+421 (0)2 5935 7416
zdenka.durackova@fmed.uniba.sk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RPv1.0
Study information
Scientific title
The influence of long term consumption of probiotics and vitamin C combination on infections in children attending preschool facilities
Acronym
PROCHILD
Study hypothesis
This study aims to investigate whether combination of probiotics and vitamin C prevents the incidence, duration and severity of upper and lower respiratory infections in children attending preschool facilities.
Ethics approval
Ethical committee of Trnava self-governing region, Trnava, Slovakia approved on the 16th of September 2010
Study design
Randomised double blind placebo controlled pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details below to request a Parental Information Sheet
Condition
Respiratory tract infections in children
Intervention
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: Xylitol
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Incidence, duration and severity of upper and lower respiratory tract infections and gastrointestinal infections.
Symptom Diary is collected on weekly basis.
Secondary outcome measures
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.
Overall trial start date
01/10/2010
Overall trial end date
30/11/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
50
Participant 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
Recruitment start date
01/10/2010
Recruitment end date
30/11/2011
Locations
Countries of recruitment
Slovakia
Trial participating centre
Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry
Bratislava
813 72
Slovakia
Funders
Funder type
Industry
Funder name
Cultech Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary