Condition category
Respiratory
Date applied
11/11/2010
Date assigned
08/04/2011
Last edited
08/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Cultech Ltd (UK)

Sponsor details

c/o Dr Nigel Plummer
Unit 3 Christchurch Road
Baglan Industrial Park
Port Talbot
SA12 7BZ
United Kingdom

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes