search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Infant formulas with prebiotics and synbiotics in Vietnam.


- candidate number3533
- NTR NumberNTR1359
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jun-2008
- Secondary IDs362/VDD-QLKH METC
- Public TitleInfant formulas with prebiotics and synbiotics in Vietnam.
- Scientific TitleEffectivity on Prevention and treatment of Infections of infants recieving NUtritional Supplementation of prebiotics and the dose-response effectivity of synbiotics in rural areas in Vietnam.
- ACRONYMEPINUS
- hypothesisThe nutritional supplementations of prebiotics and synbiotics are effective in prevention and treatment of the symptoms of infections in infants.
- Healt Condition(s) or Problem(s) studiedPrebiotics, Sinusitis, Synbiotics, Runny nose, Cough, Fecal color, Flatulence, Gastroenteritis, Diarrhea
- Inclusion criteriaHealthy infants aged from 10 to ca. 16 weeks living in Pho Yen district.
- Exclusion criteriaInfants with cows milk allergy or lactose intolerance.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 30-jun-2008
- planned closingdate29-dec-2008
- Target number of participants260
- InterventionsFood suplement intervention:
Group 1: Infant formula
Group 2: Infant formula with 0.4 g/100ml prebiotics
Group 3: Infants formula with 0.4 g/100ml prebiotics & probiotics
Group 4: Infants formula with 0.8 g/100ml prebiotics & probiotics
- Primary outcome1. Frequency of gastro-intestinal discomfort.
2. Duration of gastro-intestinal discomfort.
3. Frequency of Upper respiratory tract discomfort.
4. Duration of Upper respiratory tract discomfort.
5. Fecal microflora correlated to the respiratory and gastro-intestinal tract symptoms.
6. Dose response analysis of prebiotics when used in combination with probiotics.
- Secondary outcome1. Severity of gastro-intestinal discomfort.
2. Severity of Upper respiratory tract discomfort.
3. Fever.
4. Growth and weight.
5. Antibiotics/fungicide use.
6. Colics.
7. Atopic dermatitis.
- Timepoints- Questionaires about gastro-intestinal and respiratory symptoms will be collected weekly.
- Fecal samples will be collected at t=start, and after t=3 mths and t=6 mths intervention
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. R. Biesebeke, te
- CONTACT for SCIENTIFIC QUERIESDr. Khan Cong Nguyen
- Sponsor/Initiator Friesland Foods, Friesland Foods Dutch Lady Vietnam
- Funding
(Source(s) of Monetary or Material Support)
Friesland Foods, Friesland Foods Dutch Lady Vietnam
- PublicationsN/A
- Brief summaryThe development of a microflora community with numerous coexisting microbial species in the gastro-intestinal tract is important during the first months of life. The development of this microflora is very important as it effects the infants health. Pre-and probiotics have been shown to change the gastro-intestinal microbial composition. Current study aims to fortify the microbial composition of the gastro-intestinal tract to improve the comfort of live and to reduce the symptoms of and/or prevent from common infections in healthy growing babies in Vietnam.
- Main changes (audit trail)
- RECORD26-jun-2008 - 18-nov-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl