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Effect of the consumption of a fermented dairy product on constipation in childhood: a multi-centre randomized controlled trial.


- candidate number4654
- NTR NumberNTR1571
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-dec-2008
- Secondary IDsNU233 
- Public TitleEffect of the consumption of a fermented dairy product on constipation in childhood: a multi-centre randomized controlled trial.
- Scientific TitleEffect of the consumption of a fermented dairy product on constipation in childhood: a multi-centre randomized controlled trial.
- ACRONYMNu233
- hypothesisThe study objective is to show that Bifidobacterium animalis is effective in increasing defecation frequency after 3 weeks of product consumption in children with functional constipation.
- Healt Condition(s) or Problem(s) studiedConstipation, Children
- Inclusion criteria1. Children (boys and girls) aged from 3 to 16 years
2. Children with a diagnosis of functional constipation according to Rome III criteria (Rasquin et al.):
- subjects must present defecation frequency < 3 / week
- subjects must present 1 or more of the following criteria:
- faecal incontinence > 1 / week
- large amount of stools which clog the toilet
- painful defecation
- withholding behaviour
- abdominal or rectal faecal impaction upon physical examination
3. Children with a diagnosis of functional constipation according to Rome III criteria fulfilled for the last 2 months
4. Children with usual consumption of dairy products and ready to consume 2 pots per day
5. Children having given written consent to take part in the study (in The Netherlands: children and parents for children above 12 years and only parents for children under 12 years; in Poland: children and parents for children above 16 years and only parents for children under 16 years)
- Exclusion criteria1. Children with a diagnosis of IBS according to Rome III criteria
2. Children treated for constipation less than 2 weeks before intake in the study
3. Children with mental retardation or metabolic disease (hypothyroidism)
4. Children with Hirschsprung¡¯s disease or spinal anomalies or anorectal pathology
5. Children who underwent gastro-intestinal surgery
6. Children with functional non-retentive faecal incontinence
7. Children with lactose intolerance or known allergy to product component (milk protein for example)
8. Children who started a medication with antibiotics in the prior month
9. Children receiving medication influencing gastrointestinal motility (for examples Cisapride, Motilium, Erythromycin, laxatives, Loperamide)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2008
- planned closingdate31-dec-2008
- Target number of participants160
- InterventionsFermented dairy product Activia® (125-g pot) containing Bifidobacterium animalis DN-173 010, 1.2 1010 colony forming units (cfu) per pot and a yoghurt symbiosis Lactobacillus bulgaricus and Streptocccus thermophilus (1,2.109 cfu/pot).
- Primary outcomeThe primary endpoint is the stool frequency change from baseline to 3 weeks of product consumption.
- Secondary outcomeStool frequency over 3 weeks and at week 1 and 2 of product consumption.
- Stool consistency over 3 weeks and per week of product consumption.
- Frequency of episodes of faecal incontinence over 3 weeks and per week of product consumption.
- Pain during defecation over 3 weeks and per week of product consumption.
- Digestive symptoms: abdominal pain and flatulence over 3 weeks and per week of product consumption.
- Adverse effects: nausea, diarrhoea and bad taste over 3 weeks and per week of product consumption.
- Intake of Bisacodyl over 3 weeks and per week of product consumption.
- Rate of success defined as 3 or more bowel movements per week and less than 1 faecal incontinence episode in 2 weeks over the last 2 weeks of product consumption
- Rate of responders defined as a subject who reports a stool frequency ¡İ 3 on the last week of product consumption
- TimepointsThe total duration of the study is approximately 5 weeks for each subject. Each patient will attend 3 clinic appointments: Inclusion visit V1 (baseline), randomisation visit (V2) and clinical evaluation at weeks 3 (V3).
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESMD. PhD. Marc A. Benninga
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Marc A. Benninga
- Sponsor/Initiator Academic Medical Center (AMC), Emma Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsN/A
- Brief summary-
- Main changes (audit trail)
- RECORD2-dec-2008 - 9-dec-2008


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