A randomized controlled trial on the effect of laxative therapy in children with functional abdominal pai
Withdrawn
- Conditions
- functional abdominal painirritable bowel syndrome10017947
- Registration Number
- NL-OMON43096
- Lead Sponsor
- HagaZiekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
1. age 4-16 years;
2. chronic abdominal pain since at least 2 months;
3. organic causes excluded according to usual criteria
Exclusion Criteria
1. insufficient knowledge of the Dutch language;
2. earlier therapy with generic macrogol;
3. participation of a sibling in the study;
4. abdominal pain less than 2x per week in the diagnostic phase according to diary.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Percentage of patients being pain free (complete remission). </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Percentage decrease of the pain.<br /><br><br /><br>Clinical remission is defined as a decrease of 80%, moderate success as a<br /><br>decrease of 50-80% and lack of success as <50% decrease of the Wong-Baker Faces<br /><br>Pain Score, as noted in the diary in the last week of the run in period and the<br /><br>last week of the intervention period.<br /><br><br /><br><br /><br>2. Based on descriptive statistics an estimation will be made if the success of<br /><br>laxative therapy is specific for one or more functional abdominal pain<br /><br>syndromes (according to the Rome criteria for functional abdominal pain<br /><br>syndromes).</p><br>