The 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.
ID
Bron
Verkorte titel
Aandoening
Respiratory tract infections, gastrointestinal tract infections
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Duration of respiratory tract and gastrointestinal tract infection episode.
Achtergrond van het onderzoek
The 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.
Doel van het onderzoek
The 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.
Onderzoeksopzet
1. 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.
Onderzoeksproduct en/of interventie
Group 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.
Publiek
P.O. Box 226
Marjolijn C.E. Bragt - van Wijngaarden
Leeuwarden 8901 MA
The Netherlands
+31 (0)58 2992447
marjolijn.bragt@frieslandcampina.com
Wetenschappelijk
P.O. Box 226
Marjolijn C.E. Bragt - van Wijngaarden
Leeuwarden 8901 MA
The Netherlands
+31 (0)58 2992447
marjolijn.bragt@frieslandcampina.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Healthy Indonesian children;
2. Between 1 and <3 years of age;
3. Non-breastfed.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3362 |
| NTR-old | NTR3510 |
| Ander register | FrieslandCampina : 0.7-20120126 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |