Effect of the consumption of a fermented dairy product onconstipation in childhood: a multi-centre randomizedcontrolled trial.
Suspended
- Conditions
- Childhood constipation
- Registration Number
- NL-OMON24332
- Lead Sponsor
- Danone Research
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 160
Inclusion Criteria
1. 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.):
Exclusion Criteria
1. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the stool frequency change from baseline to 3 weeks of product consumption.
- Secondary Outcome Measures
Name Time Method Stool frequency over 3 weeks and at week 1 and 2 of product consumption.<br /><br>- Stool consistency over 3 weeks and per week of product consumption.<br /><br>- Frequency of episodes of faecal incontinence over 3 weeks and per week of product<br>consumption.<br /><br>- Pain during defecation over 3 weeks and per week of product consumption.<br /><br>- Digestive symptoms: abdominal pain and flatulence over 3 weeks and per week of product<br>consumption.<br /><br>- Adverse effects: nausea, diarrhoea and bad taste over 3 weeks and per week of product<br>consumption.<br /><br>- Intake of Bisacodyl over 3 weeks and per week of product consumption.<br /><br>- Rate of success defined as 3 or more bowel movements per week and less than 1 faecal<br>incontinence episode in 2 weeks over the last 2 weeks of product consumption<br /><br>- Rate of responders defined as a subject who reports a stool frequency ¡Ý 3 on the last week of product consumption<br>