No registrations found.
ID
Source
Brief title
Health condition
Infants with regurgitation
Sponsors and support
Intervention
Outcome measures
Primary outcome
Occurrence and severity of intestinal tolerance characteristics.
Secondary outcome
Safety and occurrence and severity of regurgitation symptoms.
Background summary
This study aims to investigate the impact of the renewed recipe compared to the currently marketed anti-reflux infant formula primarily on intestinal tolerance, and in addition on safety and efficacy of regurgitation. The study is designed as an equivalence trial of eight weeks with a run-in period on the control product for washing-out any confounding effects and will be conducted in regurgitating infants that are otherwise healthy.
Study objective
The investigational anti-reflux formula will be equivalent to the currently marketed control anti-reflux formula with regard to intestinal tolerance during eight weeks in infants with regurgitation.
Study design
1. Screening;
2. Baseline;
3. 1-week call;
4. 2-week visit;
5. 4-week visit;
6. 8-week visit.
Intervention
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.
P.O. Box 7005
C. Smeets
Wageningen 6700 CA
The Netherlands
+31 317 467 800
claudia.smeets@danone.com
P.O. Box 7005
C. Smeets
Wageningen 6700 CA
The Netherlands
+31 317 467 800
claudia.smeets@danone.com
Inclusion criteria
1. Healthy term infants (37-42 weeks gestation at birth);
2. Age <= 3 months at screening;
3. >= 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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1732 |
| NTR-old | NTR1842 |
| Other | Danone Research B.V. : UAR 2 C/A |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |