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

A 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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21383

Enrollment

130

Registered

2010-04-07

Start date

2010-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy toddlers

Interventions

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

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Ratio bifidobacteria to total faecal bacteria.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactXuchen Li

PO Box 7005

xuchen.li@danone.com+31 (0)317 467855

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)