Skip to content

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

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43096
Enrollment
120
Registered
2016-05-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

functional abdominal pain irritable bowel syndrome

Interventions

Macrogol 4000, generic form with addition of a flavouring, 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 inc

Sponsors

HagaZiekenhuis
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Percentage of patients being pain free (complete remission).

Secondary

MeasureTime 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

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)