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van CCT (UK)

van CCT (UK)

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

- candidate number3122
- NTR NumberNTR1234
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-mrt-2008
- Public TitleCombining prebiotics or/and probiotics to improve the immunity of Children.
- Scientific TitleThe effect of Prebiotics or/and Probiotics on common infections of young children in Indonesia through impact on the Gastrointestinal Microbial Species Composition.
- hypothesisThe Prebiotic (GOS=Galactooligosaccharides) or/and Probiotics (L. paracasei/B.animalis) change the microbial composition at the species level in the gastro-intestinal tract and effect common infections located in the GI-tract and the respiratory tract of children aged 1-5 years in Indonesia.
- Healt Condition(s) or Problem(s) studiedProbiotics, Microbial composition, Gut health, Gut integrity, Immune system
- Inclusion criteria1. Healthy children
2. Age between 1-5 years
3. Informed consent
4. Parents of the kids living in Surabaya (Indonesia)
- Exclusion criteriaChildren with:
1. Crohns, atopic disease.
2. Severe malnutrition (CDC-NCHS/Z-score)
3. History of Allergy cow's milk
4. History of Lactose intolerance
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2007
- planned closingdate3-jun-2008
- Target number of participants240
- InterventionsThe 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 the following groups:

1) Growing up milk
2) Growing up milk with prebiotics
(Glalactooligosacchariden) 3) Grow ing up milk with probiotics (Lactobacillus paracasei and Bifidobacterium animalis)
4) Growing up milk with probiotics (Lactobacillus paracasei and Bifidobacterium animalis) and prebiotics (Galalactooligosacchariden)
- Primary outcomeWeekly 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 outcomeWeekly questionaires with:
1) Behaviour of the child
2) Allergy symptoms (eczema, hay fever, asthma etc.)
3) Fever
4) Day care attendance
- TimepointsHealth Questionaires: weekly
Growth & development parameters: weekly/monthly
Fecal samples: 0, 1, 3, 6 months
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT for SCIENTIFIC QUERIESProf. Dr. H. Subijanto Marto Sudarmo Spa
- Sponsor/Initiator Frisian Flag, Jakarata, Indonesia , BPPT, Jakarta, Indonesia , Soetomo Hospital, Surabaja, Indonesia , Friesland Foods, Leeuwarden (Global Development Centre)
- Funding
(Source(s) of Monetary or Material Support)
Friesland Foods, Leeuwarden , Frisian Flag, Jakarata, Indonesia, BPPT, Jakarta, Indonesia , Soetomo Hospital, Surabaja, Indonesia
- PublicationsN/A
- Brief summaryThe gastro-intestinal tract contains numerous coexisting microbial species that effect human health. Pre-and probiotics have been shown to change the gastro-intestinal microbial composition. Current study aims to fortify the microbial composition of the gastro-intestinal tract and through that effect the resistance against infection of the children. The aim of present study was to study the effect of consumption of pre-, pro-, and synbiotics formula on 1) GI-tract microflora, 2) in preventing infectious illnesses (GI-tract and URT) and 3) growth and development status of/in Indonesian children aged 1-5.
- Main changes (audit trail)
- RECORD18-mrt-2008 - 16-apr-2011

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