|- candidate number||3533|
|- NTR Number||NTR1359|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-jun-2008|
|- Secondary IDs||362/VDD-QLKH METC|
|- Public Title||Infant formulas with prebiotics and synbiotics in Vietnam.|
|- Scientific Title||Effectivity 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.|
|- hypothesis||The 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) studied||Prebiotics, Sinusitis, Synbiotics, Runny nose, Cough, Fecal color, Flatulence, Gastroenteritis, Diarrhea|
|- Inclusion criteria||Healthy infants aged from 10 to ca. 16 weeks living in Pho Yen district.
|- Exclusion criteria||Infants with cows milk allergy or lactose intolerance.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||30-jun-2008|
|- planned closingdate||29-dec-2008|
|- Target number of participants||260|
|- Interventions||Food 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 outcome||1. 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 outcome||1. Severity of gastro-intestinal discomfort.|
2. Severity of Upper respiratory tract discomfort.
4. Growth and weight.
5. Antibiotics/fungicide use.
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 site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. R. Biesebeke, te|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Khan Cong Nguyen|
|- Sponsor/Initiator ||Friesland Foods, Friesland Foods Dutch Lady Vietnam|
(Source(s) of Monetary or Material Support)
|Friesland Foods, Friesland Foods Dutch Lady Vietnam|
|- Brief summary||The 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)|
|- RECORD||26-jun-2008 - 18-nov-2008|