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

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

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46175

Enrollment

Registered

2017-12-11

Start date

2017-07-04

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

functional abdominal pain

Interventions

Macrogol 4000, generic form, is used as laxative. Starting dosage is 20 g/day in 200 ml fluid per 10 g macrogol. In case of insufficient result, the dosage is to be increased with 10 g/day (in extra

Children

Constipation

Functional abdominal pain

Rome criteria

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Pain score (Wong-Baker Faces Pain Score) as registered in the diary.	—

Secondary

Measure	Time frame
1. Percentage decrease of the pain. Clinical remission is defined as a decrease of 80%, moderate success as a decrease of 50-80% and lack of success as	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)