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A randomised, controlled, double-blind trial to evaluate intestinal tolerance of a renewed anti-reflux formula in infants with regurgitation.


- candidate number5891
- NTR NumberNTR1842
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jun-2009
- Secondary IDsUAR 2 C/A Danone Research B.V.
- Public TitleA randomised, controlled, double-blind trial to evaluate intestinal tolerance of a renewed anti-reflux formula in infants with regurgitation.
- Scientific TitleA randomised, controlled, double-blind trial to evaluate intestinal tolerance of a renewed anti-reflux formula in infants with regurgitation.
- ACRONYMPUP study
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedChildren, Regurgitation
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 11-jun-2009
- planned closingdate31-dec-2009
- Target number of participants98
- InterventionsRun-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.
- Primary outcomeOccurrence and severity of intestinal tolerance characteristics.
- Secondary outcomeSafety and occurrence and severity of regurgitation symptoms.
- Timepoints1. Screening;
2. Baseline;
3. 1-week call;
4. 2-week visit;
5. 4-week visit;
6. 8-week visit.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMSc C. Smeets
- CONTACT for SCIENTIFIC QUERIESPhD M. Alles
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsN/A
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD8-jun-2009 - 30-aug-2011


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