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Is Bifidobacterium breve effective in the treatment of childhood constipation?

Conditions
constipation
stool problem
10017977
Registration Number
NL-OMON33537
Lead Sponsor
Yakult Nederland B.V.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

At least 2 or more of the following criteria for at least 8 weeks:
1. Defecation frequency <3/week
2. Faecal incontinence >1/week
3. Large amount of stools which clog the toilet
4. Painful defecation
5. Withholding behaviour
6. Abdominal or rectal faecal impaction upon physical examination

Exclusion Criteria

1. Mental retardation/metabolic disease (hypothyroidism)
2. Hirschsprung's disease/ spinal abnomalies/ anorectal pathology
3. Children who underwent gastro-intestinal surgery
4. Children with functional non-retentive faecal incontinence
5. Use of laxatives two weeks prior to the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Defecation frequency</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- Stool consistency<br /><br>- Pain during defecation<br /><br>- The frequency of faecal incontinence episodes<br /><br>- Adverse effects<br /><br>- Use of Bisacodyl</p><br>
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