Infant formulas with prebiotics and synbiotics in Vietnam.
Recruiting
- Conditions
- Gastro-intestinal comfort (diahrroea, gastro-enteritis, flatulence, fecal color, fecal microflora,....), respiratory tract comfort (cough, runny nose, sinusitis..), and (medical) treatment.
- Registration Number
- NL-OMON26620
- Lead Sponsor
- Friesland Foods Dutch Lady Vietnam, Binh Duong, Vietnam; Friesland Foods, Leeuwarden/Meppel, the Netherlands, (National Institute of Nutrition)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 260
Inclusion Criteria
Healthy infants aged from 10 to ca. 16 weeks living in Pho Yen district.
Exclusion Criteria
Infants with cows milk allergy or lactose intolerance.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Frequency of gastro-intestinal discomfort.<br /><br>2. Duration of gastro-intestinal discomfort.<br /><br>3. Frequency of Upper respiratory tract discomfort.<br /><br>4. Duration of Upper respiratory tract discomfort.<br /><br>5. Fecal microflora correlated to the respiratory and gastro-intestinal tract symptoms.<br /><br>6. Dose response analysis of prebiotics when used in combination with probiotics.
- Secondary Outcome Measures
Name Time Method 1. Severity of gastro-intestinal discomfort.<br /><br>2. Severity of Upper respiratory tract discomfort.<br /><br>3. Fever.<br /><br>4. Growth and weight.<br /><br>5. Antibiotics/fungicide use.<br /><br>6. Colics.<br /><br>7. Atopic dermatitis.<br />