Laxative therapy in children with functional abdominal pain

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24535

Enrollment

Registered

2016-11-20

Start date

2016-11-24

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. Chronic abdominal pain. Children. Laxatives. Rome criteria.

Interventions

Macrogol 4000, starting dosage 20 g/day, to increase every 2 days with 10 g in case of insufficient result until a maximum dosage of 50 g/day. The dosage should be adjusted guided by the stool consist

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 4-16 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 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): % with score 0 (pain free)	—

Secondary

Measure	Time frame
Pain score: % decrease of pain in last week of intervention phase versus last week of run-in phase.	—

Contacts

Public ContactCarolien F.M. Gijsbers

Danckertsstraat 21

cfm.gijsbers@planet.nl+31.(0)70 3463443

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)