PROCHILD: Probiotics in prevention of respiratory tract infections
| ISRCTN | ISRCTN28722693 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28722693 |
| Protocol serial number | RPv1.0 |
| Sponsor | Cultech Ltd (UK) |
| Funder | Cultech Ltd (UK) |
- 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
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 |
|---|---|
| zdenka.durackova@fmed.uniba.sk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind placebo controlled pilot study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The influence of long term consumption of probiotics and vitamin C combination on infections in children attending preschool facilities |
| Study acronym | PROCHILD |
| Study objectives | 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(s) | Ethical committee of Trnava self-governing region, Trnava, Slovakia approved on the 16th of September 2010 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Incidence, duration and severity of upper and lower respiratory tract infections and gastrointestinal infections. |
| Key secondary outcome measure(s) |
1. Changes in key immunological parameters and markers of oxidative stress |
| Completion date | 30/11/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 6 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2010 |
| Date of final enrolment | 30/11/2011 |
Locations
Countries of recruitment
- Slovakia
Study participating centre
Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry
Bratislava
813 72
Slovakia
813 72
Slovakia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
