Infants with regurgitation
Conditions
Interventions
Run-in period of 2 to 4 weeks on control product, followed by 8 weeks randomised on either investigational or control product. The investigational product is a renewed anti-reflux formula
the control product is the currently marketed anti-reflux formula.
Sponsors
Danone Research – Centre for Specialised Nutrition
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy term infants (37-42 weeks gestation at birth); 2. Age = 3 episodes of regurgitation/day at screening; 4. >= 75% formula feeding; 5. Parent's written informed consent; 6. Parent's willingness and ability to comply with the protocol requirements.
Exclusion criteria
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; 3. Use within 4 weeks prior to randomisation and/or anticipated use during study of: A. Probiotics; B. Prebiotics (except for human milk); C. Antibiotics; D. Cisapride, metoclopramide, proton pump inhibitors, H2 receptor antagonists; E. Anti-reflux formula (except for assigned study product); F. Locust Bean Gum (e.g. Nutrilon Nutriton); G. Weaning food including rice flour (restricted only during run-in and first 4-week investigational period); H. Other investigational products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence and severity of intestinal tolerance characteristics. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and occurrence and severity of regurgitation symptoms. | — |
Contacts
Public ContactC. Smeets
Danone Research, P.O. Box 7005
Outcome results
None listed