A study on the effect of laxative therapy in children with abdominal pain without somatic cause

Phase 1

Conditions: Functional abdominal pain
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2014-005467-32-NL

Lead Sponsor: Haga Teaching Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 80

Inclusion Criteria

1. age 4-18 years; and
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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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’ (Rome IV criteria)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish the effectiveness of laxative therapy in children with functional abdominal pain;Secondary Objective: To establish if laxative therapy is effective in all functional abdominal pain syndromes, according to the Rome criteria, including functional dyspepsia and the diarrhea variant of irritable bowel syndrome;Primary end point(s): Percentage of patients being pain free by laxative measures;Timepoint(s) of evaluation of this end point: After 4 weeks of therapy and at follow up 6 months later

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Percentage decrease of pain score by laxative measures;Timepoint(s) of evaluation of this end point: After 4 weeks of therapy and at follow up 6 months later