No registrations found.
ID
Source
Brief title
Health condition
Healthy toddlers
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ratio bifidobacteria to total faecal bacteria.
Secondary outcome
1. 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.
Background summary
The 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.
Study objective
A positive effect of the investigational product on the intestinal microbiota of healthy Asian toddlers is expected.
Study design
The 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.
Intervention
Duration 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.
Inclusion criteria
1. 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 criteria
1. 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.
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 | NL2148 |
| NTR-old | NTR2273 |
| Other | Danone Research : Tod.1.C/F / |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |