Study on the effects of an infant formula on stool in healthy infants
- Conditions
- Stool consistencyGastrointestinal (dis)comfort
- Registration Number
- NL-OMON19941
- Lead Sponsor
- FrieslandCampina
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
Healthy and term infants (gestational age >= 37 and <= 42 weeks)
- Infants who are partially formula fed (> 500 mL formula/day) or exclusively formula fed
Exclusion Criteria
- Congenital condition and/or previous or current illness that could interfere with study
- Known or increased risk of cow's milk allergy and/ or lactose intolerance (i.e. one of the biological parents and or siblings diagnosed with cow's milk allergy, asthma, hay fever, etc.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Stool consistency<br /><br>- Protein and fat digestion
- Secondary Outcome Measures
Name Time Method - Stool frequency<br /><br>- Stool amount<br /><br>- Stool color<br /><br>- Gastrointestinal symptoms<br /><br>- Crying time<br /><br>- Fecal parameters<br /><br>