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

A randomised controlled trial on the effect of laxative therapy in children with functional abdominal pain - Laxative therapy in children with functional abdominal pain

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005467-32-NL

Enrollment

Registered

2016-07-18

Start date

2016-08-08

Completion date

Unknown

Last updated

2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional abdominal pain

Interventions

Trade Name: Forlax Product Name: macrogol 4000 = polyethylene glycol 4000 Product Code: generic product Pharmaceutical Form: Powder for oral solution Pharmaceutical form of the placebo: Powder for ora

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Netherlands

Contacts

Public ContactClinical Trial Coordinator

Office of the Clinical Trial Coordinator, Haga Teaching Hospital

+31(0)70210 0000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026