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van CCT (UK)

Growing up milk with new fat composition and probiotics to target infections in Indonesian toddlers.

- candidate number13110
- NTR NumberNTR3510
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jul-2012
- Secondary IDs0.7-20120126 FrieslandCampina
- Public TitleGrowing up milk with new fat composition and probiotics to target infections in Indonesian toddlers.
- Scientific TitleThe effects of a growing-up milk containing an optimised fat blend and probiotics on symptoms of gastrointestinal and respiratory infections in Indonesian children between 1 and 3 years of age.
- hypothesisThe growing-up milk products with a new fat composition and probiotics are effective to reduce the duration and symptoms of respiratory and gastrointestinal tract infections.
- Healt Condition(s) or Problem(s) studiedRespiratory infections, Gastro-intestinal infections
- Inclusion criteria1. Healthy Indonesian children;
2. Between 1 and <3 years of age;
3. Non-breastfed.
- Exclusion criteria1. In sick condition 1 month before the start of the study;
2. Receiving antibiotics treatment 2 weeks before the study starts;
3. Breastfeeding 2 months prior to the start of the intervention period;
4. Consumption of pre-, pro- or synbiotic products at least 2 weeks prior to the intervention;
5. Symptoms of chronic/congenital diseases and disabilities, suspected Tuberculosis by clinical examination, and/or history of allergic diseases;
6. Use of medication that can interfere with the study 2 months before the start, such as strong anti-inflammatory drugs;
7. History of lactose intolerance;
8. History of cow’s milk allergy;
9. Siblings of already included children that are living in the same household, except if it is a twin sibling;
10. Participation in another clinical trial at the same time or 2 months prior to the study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2012
- planned closingdate31-dec-2013
- Target number of participants300
- InterventionsGroup 1: Standard Growing up milk;
Group 2: Growing up milk + new fat blend;
Group 3: Growing up milk + new fat blend + probiotic 1;
Group 4: Growing up milk + new fat blend + probiotic 2.
- Primary outcomeDuration of respiratory tract and gastrointestinal tract infection episode.
- Secondary outcome1. Incidence of infection;
2. Severity of infection;
3. Physical growth;
4. Rotavirus prevalence;
5. Gut microflora;
6. Mucosal inflammation.
- Timepoints1. Weekly symptom monitoring via questionnaire;
2. Visits at t=0, t=1, t=2, t=3, t=4, t=6, t=8, t=10 and t=12 months;
3. Fecal sample collection at t=0, t=4, t=8 and t=12 months and in case of acute diarrhea.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Marjolijn C.E. Bragt - van Wijngaarden
- CONTACT for SCIENTIFIC QUERIESDr. Marjolijn C.E. Bragt - van Wijngaarden
- Sponsor/Initiator FrieslandCampina Innovation Infant &Toddler Nutrition
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryThe leading causes of death in children under 5 years of age are respiratory tract infections and diarrhea. Young children, and especially toddlers, encounter many pathogenic microorganisms including viruses, bacteria and parasites, making it of major importance to target these diseases. There are complex processes underlying gastrointestinal tract and respiratory tract infections. Adequate and high quality nutrition can play a pivotal role in reducing infection risk. This study investigates the the effects of growing up milks containing an optimized fat blend with and without probiotics on 1. duration and incidence of respiratory tract and gastrointestinal tract infections, 2. gut microflora, mucosal inflammation and rotavirus prevalence, and 3. physical growth. The study will be performed in 300 Indonesian toddlers between 1 and 3 years of age.
- Main changes (audit trail)
- RECORD5-jul-2012 - 13-jul-2012

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