A randomised, controlled, double-blind trial to evaluate intestinal tolerance of a renewed anti-reflux formula in infants with regurgitation.
Completed
- Conditions
- Infants with regurgitation
- Registration Number
- NL-OMON21625
- Lead Sponsor
- Danone Research – Centre for Specialised Nutrition
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 98
Inclusion Criteria
1. Healthy term infants (37-42 weeks gestation at birth);
2. Age <= 3 months at screening;
Exclusion Criteria
1. Clinically significant congenital disease including gastroesophageal, respiratory, and neurological disorders, (suspicion of) food allergies, and disease affecting normal growth;
2. Gastrointestinal infection within 4 weeks prior to randomisation;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method