A randomised controlled trial on the effect of laxative therapy in children with functional abdominal pai

Completed

Conditions: functional abdominal pain
10017947
irritable bowel syndrome

Registration Number: NL-OMON46175

Lead Sponsor: HagaZiekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

1. age 4-18 years;
2. fulfilling the Rome IV criteria for functional abdominal pain disorders, with exception of the criterion for IBS-patients that the pain does not resolve with resolution of the constipation.

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.
5. diagnosis *functional constipation* according to the Rome IV criteria.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pain score (Wong-Baker Faces Pain Score) as registered in the diary.</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>2. Based on descriptive statistics an estimation will be made if the success of<br /><br>laxative therapy is specific for one or more specific functional pain<br /><br>syndromes, according to the Rome criteria.</p><br>