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

Conditions: constipation
10017943

Registration Number: NL-OMON30819

Lead Sponsor: Danone Vitapole

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Children (3 - 16 years of age) with untreated constipation fulfilling the Rome III-criteria: ;1) Defecation frequency < 3/week ;And at least 1 or more of the following criteria:
2) Fecal incontinence > 1 /week
3) Large amount of stools which clog the toilet
4) Painful defecation
5) Withholding behavior
6) Abdominal or rectal fecal impaction upon physical examination

Exclusion Criteria

1) Children treated for constipation
2) Mental retardation / metabolic disease (hypothyroidism)
3) Hirschsprung*s disease / spinal anomalies / anorectal pathology
4) Children who underwent gastro-intestinal surgery
5) Children with functional non-retentive fecal incontinence
6) Children with cow's milk allergy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure:<br /><br>Effect on stool frequency at 3 weeks. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes:<br /><br>- Effect on stool frequency over 3 weeks.<br /><br><br /><br>- Effect on stool consistency over 3 weeks.<br /><br><br /><br>- Effect on frequency of episodes of faecal incontinence over 3 weeks.<br /><br><br /><br>- Effect on pain during defecation over 3 weeks.<br /><br><br /><br>- Effect on digestive symptoms (abdominal pain and flatulence) over 3 weeks.<br /><br><br /><br>- Effect on adverse effects (nausea, diarrhea and bad taste) over 3 weeks.<br /><br><br /><br>- Effect on rate of success defined as three or more bowel movements per week<br /><br>and less than 1 faecal incontinence episode over the last 2 weeks of product<br /><br>consumption.<br /><br><br /><br>- Effect on rate of responders according to stool frequency at 3 weeks (a<br /><br>responder will be defined as a subject who has a stool frequency of 3 or more<br /><br>on the last week of product consumption).<br /><br><br /><br>- Effect on intake of Bisacodyl over 3 weeks.<br /><br></p><br>