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Study to explore the effect of a Growing Up Milk with added synbiotics on the intestinal microbiota of healthy Asian toddlers.


- candidate number7906
- NTR NumberNTR2273
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-apr-2010
- Secondary IDsTod.1.C/F / Danone Research
- Public TitleStudy to explore the effect of a Growing Up Milk with added synbiotics on the intestinal microbiota of healthy Asian toddlers.
- Scientific TitleA randomised, double-blind, controlled study to explore the effect of a Growing Up Milk with added synbiotics on the intestinal microbiota composition of healthy Asian toddlers.
- ACRONYMSMILE
- hypothesisA positive effect of the investigational product on the intestinal microbiota of healthy Asian toddlers is expected.
- Healt Condition(s) or Problem(s) studiedHealthy toddlers
- Inclusion criteria1. Healthy Asian subjects between 1 and 3 years of age;
2. Expected study product intake 500 - 650 ml per day;
3. Access to a freezer or a refrigerator with an ice tray for temporary storage of stool samples;
4. Written informed consent from parents.
- Exclusion criteria1. Being breastfed in the 4 weeks before inclusion;
2. Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special toddler formula is required);
3. Significant congenital abnormality that will interfere with the study objectives in the opinion of the investigator;
4. Risk factors on infection linked to probiotics, such as cardiac insufficiency and cardiac abnormalities including cardiac malformation, or immunodeficiency;
5. Use of oral/systemic antibiotics or anti-mycotic medication in the 4 weeks preceding the study screening or expected use during the study;
6. Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements;
7. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2010
- planned closingdate1-jan-2011
- Target number of participants130
- InterventionsDuration of intervention: 12 weeks;
Intervention group: 65;
Control group: 65. The intervention group will receive Growing Up Milk with added synbiotics. This is powder-based Growing Up Milk (GUM) with added prebiotics (scGOS/lcFOS), probiotics (B. breve M-16V) and LCPUFA. The control group will receive Growing Up Milk with added LCPUFA, but without the prebiotics.
- Primary outcomeRatio bifidobacteria to total faecal bacteria.
- Secondary outcome1. Ratio of other bacteria groups to total faecal bacteria;
2. Faecal short chain fatty acids;
3. Faecal lactate;
4. Faecal pH;
5. Faecal secretory IgA;
6. Parent's reported symptoms of illness.
- TimepointsThe whole intervention phase will take 12 weeks.
V1: screening (week -1);
V2: baseline (week 0);
Contact 1: week 1;
V3: week 6;
V4: week 12;
Contact 2: week 14.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD. Msc. BSc. Xuchen Li
- CONTACT for SCIENTIFIC QUERIESPhD. Msc. BSc. Xuchen Li
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- PublicationsN/A
- Brief summaryThe effect of a Growing up milk with added synbiotics will be compared with the effect of a Growing up milk without added synbiotics on the intestinal microbiota of healthy Asian toddlers in a 12-weeks, randomised, double blind controlled intervention study.
- Main changes (audit trail)
- RECORD7-apr-2010 - 16-apr-2010


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