A positive effect of the investigational product on the intestinal microbiota of healthy Asian toddlers is expected.
ID
Bron
Verkorte titel
Aandoening
Healthy toddlers
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Ratio bifidobacteria to total faecal bacteria.
Achtergrond van het onderzoek
The effect of a Growing up milk with added synbiotics will be compared with the effect of a Growing up milk without added synbiotics on the intestinal microbiota of healthy Asian toddlers in a 12-weeks, randomised, double blind controlled intervention study.
Doel van het onderzoek
A positive effect of the investigational product on the intestinal microbiota of healthy Asian toddlers is expected.
Onderzoeksopzet
The whole intervention phase will take 12 weeks.
V1: screening (week -1);
V2: baseline (week 0);
Contact 1: week 1;
V3: week 6;
V4: week 12;
Contact 2: week 14.
Onderzoeksproduct en/of interventie
Duration of intervention: 12 weeks;
Intervention group: 65;
Control group: 65.
The intervention group will receive Growing Up Milk with added synbiotics. This is powder-based Growing Up Milk (GUM) with added prebiotics (scGOS/lcFOS), probiotics (B. breve M-16V) and LCPUFA. The control group will receive Growing Up Milk with added LCPUFA, but without the prebiotics.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Healthy Asian subjects between 1 and 3 years of age;
2. Expected study product intake 500 - 650 ml per day;
3. Access to a freezer or a refrigerator with an ice tray for temporary storage of stool samples;
4. Written informed consent from parents.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Being breastfed in the 4 weeks before inclusion;
2. Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special toddler formula is required);
3. Significant congenital abnormality that will interfere with the study objectives in the opinion of the investigator;
4. Risk factors on infection linked to probiotics, such as cardiac insufficiency and cardiac abnormalities including cardiac malformation, or immunodeficiency;
5. Use of oral/systemic antibiotics or anti-mycotic medication in the 4 weeks preceding the study screening or expected use during the study;
6. Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements;
7. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2148 |
| NTR-old | NTR2273 |
| Ander register | Danone Research : Tod.1.C/F / |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |