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Combining prebiotics or/and probiotics to improve the immunity of Children.

Completed
Conditions
Microbial composition of the GI-tract, Gut health, Gut integrity, Severity and Frequency of common infections and side effects (like e.g common cold, flue, fever, diarrhoea, Defecation patern, Earinfection, Behaviour, Sleeping patterns, etc.)
Registration Number
NL-OMON27904
Lead Sponsor
Frisian Flag (initiator/sponsor), Jakarata, Indonesia / BPPT, Jakarta, Indonesia / Soetomo Hospital, Surabaja, Indonesia / Friesland Foods, Leeuwarden (Sponsor/ initiator),The Netherlands
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
240
Inclusion Criteria

1. Healthy children

2. Age between 1-5 years

Exclusion Criteria

Children with:

1. Crohns, atopic disease.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Weekly questionaires are filled in by the caregivers (and in severe case:P diagnose by the specialist): <br /><br>1) the length of diarhoea <br /><br>2) the number of diarrhoea episodes <br /><br>3) severity of diarrhea<br /><br>4) the length of upper respiratory tract infections (UTRI) <br /><br>5) the number of UTRI <br /><br>6) severity of URTI. <br /><br><br /><br>Monthly data will be colected on: <br /><br>1) children growth-development status<br /><br><br /><br>Fecal samples are taken at time piont: 0 months, 1 months, 3 months and 6 months
Secondary Outcome Measures
NameTimeMethod
Weekly questionaires with:<br /><br>1) Behaviour of the child<br /><br>2) Allergy symptoms (eczema, hay fever, asthma etc.)<br /><br>3) Fever<br /><br>4) Day care attendance<br />
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