A randomised, double blind, controlled study on the effect of Growing up milk on the intestinal microbiota in toddlers.
- Conditions
- healthy
- Registration Number
- NL-OMON22837
- Lead Sponsor
- Danone Research B.V.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 195
Inclusion Criteria
1. Healthy subjects between 1 and 3 years of age;
2. Expected study product intake of 500 – 650 ml per day;
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);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 1. Parent’s reported symptoms of illness (with special focus on infections);<br /><br>2. Faecal secretory IgA;<br /><br>3. Faecal short chain fatty acids (SCFA);<br /><br>4. Faecal lactate;<br /><br>5. Faecal pH.<br>