A positive effect of a Growing Up Milk with added prebiotics or prebiotics and LCPUFA on the intestinal microbiota of toddlers.
ID
Bron
Verkorte titel
Aandoening
healthy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To investigate the effect of the investigational products I and II compared to the control product on the intestinal microbiota composition in healthy toddlers.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
A positive effect of a Growing Up Milk with added prebiotics or prebiotics and LCPUFA on the intestinal microbiota of toddlers.
Onderzoeksopzet
1. First patient in: 1-mrt-2010;
2. Last patient in: 1-may-2010;
3. Last patient out: 1-sep-2010.
Onderzoeksproduct en/of interventie
Nutritional intervention starting between the age of 12 to 36 month after birth with formula feeding in a double-blind, randomised, parallel manner.
Publiek
Tarik Hessabi
Bosrandweg 20, 6704 PH Wageningen
Wageningen 6700 CA
The Netherlands
+31 (0)317 467800
tarik.hessabi@danone.com
Wetenschappelijk
Tarik Hessabi
Bosrandweg 20, 6704 PH Wageningen
Wageningen 6700 CA
The Netherlands
+31 (0)317 467800
tarik.hessabi@danone.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Healthy subjects between 1 and 3 years of age;
2. Expected study product intake of 500 – 650 ml per day;
3. Written informed consent from both parents or legal representatives.
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 subject or toddler formula is required);
3. Significant congenital abnormality that could affect the study results;
4. Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks preceding the study or expected use during the study;
5. Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements;
6. 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
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2044 |
| NTR-old | NTR2161 |
| Ander register | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |