healthy
Conditions
Interventions
Nutritional intervention starting between the age of 12 to 36 month after birth with formula feeding in a double-blind, randomised, parallel manner.
Sponsors
Danone Research B.V.
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactTarik Hessabi
P.O. Box 7005
Outcome results
None listed