No registrations found.
ID
Source
Brief title
Health condition
healthy
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate the effect of the investigational products I and II compared to the control product on the intestinal microbiota composition in healthy toddlers.
Secondary outcome
1. Parent’s reported symptoms of illness (with special focus on infections);
2. Faecal secretory IgA;
3. Faecal short chain fatty acids (SCFA);
4. Faecal lactate;
5. Faecal pH.
Background summary
N/A
Study objective
A positive effect of a Growing Up Milk with added prebiotics or prebiotics and LCPUFA on the intestinal microbiota of toddlers.
Study design
1. First patient in: 1-mrt-2010;
2. Last patient in: 1-may-2010;
3. Last patient out: 1-sep-2010.
Intervention
Nutritional intervention starting between the age of 12 to 36 month after birth with formula feeding in a double-blind, randomised, parallel manner.
Tarik Hessabi
Bosrandweg 20, 6704 PH Wageningen
Wageningen 6700 CA
The Netherlands
+31 (0)317 467800
tarik.hessabi@danone.com
Tarik Hessabi
Bosrandweg 20, 6704 PH Wageningen
Wageningen 6700 CA
The Netherlands
+31 (0)317 467800
tarik.hessabi@danone.com
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2044 |
| NTR-old | NTR2161 |
| Other | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |