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A randomised, double blind, controlled study on the effect of Growing up milk on the intestinal microbiota in toddlers.


- candidate number6874
- NTR NumberNTR2161
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-jan-2010
- Secondary IDs 
- Public TitleA randomised, double blind, controlled study on the effect of Growing up milk on the intestinal microbiota in toddlers.
- Scientific TitleStudy to explore the effect of Growing Up Milk with added prebiotics or with added prebiotics and LCPUFA on the intestinal microbiota of toddlers.
- ACRONYMPEARL
- hypothesisA positive effect of a Growing Up Milk with added prebiotics or prebiotics and LCPUFA on the intestinal microbiota of toddlers.
- Healt Condition(s) or Problem(s) studiedHealthy toddlers
- Inclusion criteria1. Healthy subjects between 1 and 3 years of age;
2. Expected study product intake of 500 – 650 ml per day;
3. Written informed consent from both parents or legal representatives.
- 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 subject or toddler formula is required);
3. Significant congenital abnormality that could affect the study results;
4. Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks preceding the study or expected use during the study;
5. Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements;
6. 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 trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2010
- planned closingdate1-sep-2010
- Target number of participants195
- InterventionsNutritional intervention starting between the age of 12 to 36 month after birth with formula feeding in a double-blind, randomised, parallel manner.
- Primary outcomeTo investigate the effect of the investigational products I and II compared to the control product on the intestinal microbiota composition in healthy toddlers.
- Secondary outcome1. Parent’s reported symptoms of illness (with special focus on infections);
2. Faecal secretory IgA;
3. Faecal short chain fatty acids (SCFA);
4. Faecal lactate;
5. Faecal pH.
- Timepoints1. First patient in: 1-mrt-2010;
2. Last patient in: 1-may-2010;
3. Last patient out: 1-sep-2010.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD Tarik Hessabi
- CONTACT for SCIENTIFIC QUERIESPhD Tarik Hessabi
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD12-jan-2010 - 20-jan-2010


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