PROCHILD: Probiotics in prevention of respiratory tract infections

ISRCTN ISRCTN28722693
DOI https://doi.org/10.1186/ISRCTN28722693
Secondary identifying numbers RPv1.0
Submission date
11/11/2010
Registration date
08/04/2011
Last edited
08/04/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Zdenka Durackova
Scientific

Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry
Medical School
Comenius University
Sasinkova 2
Bratislava
813 72
Slovakia

Phone +421 (0)2 5935 7416
Email zdenka.durackova@fmed.uniba.sk

Study information

Study designRandomised double blind placebo controlled pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use contact details below to request a Parental Information Sheet
Scientific titleThe influence of long term consumption of probiotics and vitamin C combination on infections in children attending preschool facilities
Study acronymPROCHILD
Study objectivesThis 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(s)Ethical committee of Trnava self-governing region, Trnava, Slovakia approved on the 16th of September 2010
Health condition(s) or problem(s) studiedRespiratory tract infections in children
InterventionParticipants 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 typeOther
Primary outcome measureIncidence, duration and severity of upper and lower respiratory tract infections and gastrointestinal infections.
Symptom Diary is collected on weekly basis.
Secondary outcome measures1. 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 study start date01/10/2010
Completion date30/11/2011

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
Upper age limit6 Years
SexBoth
Target number of participants50
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/10/2010
Date of final enrolment30/11/2011

Locations

Countries of recruitment

  • Slovakia

Study participating centre

Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry
Bratislava
813 72
Slovakia

Sponsor information

Cultech Ltd (UK)
Industry

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

ROR logo "ROR" https://ror.org/00555bk04

Funders

Funder type

Industry

Cultech Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan