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

The effect of Prebiotics or/and Probiotics on common infections of young children in Indonesia through impact on the Gastrointestinal Microbial Species Composition.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27904
Enrollment
240
Registered
2008-03-18
Start date
2007-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.)

Interventions

The intervention takes place during 9 months in which there are 2 timepionts of inclusion. Children drink 300-800 ml (amount is registred) formula per day during a period of 6 months. The studie has t

Sponsors

Frisian Flag (initiator/sponsor), Jakarata, Indonesia / BPPT, Jakarta, Indonesia / Soetomo Hospital, Surabaja, Indonesia / Friesland Foods, Leeuwarden (Sponsor/ initiator), The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy children 2. Age between 1-5 years 3. Informed consent 4. Parents of the kids living in Surabaya (Indonesia)

Exclusion criteria

Exclusion criteria: Children with: 1. Crohns, atopic disease. 2. Severe malnutrition (CDC-NCHS/Z-score) 3. History of Allergy cow's milk 4. History of Lactose intolerance

Design outcomes

Primary

MeasureTime frame
Weekly questionaires are filled in by the caregivers (and in severe case:P diagnose by the specialist): 1) the length of diarhoea 2) the number of diarrhoea episodes 3) severity of diarrhea 4) the length of upper respiratory tract infections (UTRI) 5) the number of UTRI 6) severity of URTI. Monthly data will be colected on: 1) children growth-development status Fecal samples are taken at time piont: 0 months, 1 months, 3 months and 6 months

Secondary

MeasureTime frame
Weekly questionaires with: 1) Behaviour of the child 2) Allergy symptoms (eczema, hay fever, asthma etc.) 3) Fever 4) Day care attendance

Contacts

Public ContactR. Biesebeke, te

Friesland Foods Pieter Stuyvesantweg 1

rob.tebiesebeke@frieslandfoods.com++31612504012

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)