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Laxative therapy in children with functional abdominal pain


- candidate number25555
- NTR NumberNTR6110
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-nov-2016
- Secondary IDs2014-005467-32, NL57969.098.16 EudraCT, ABR dossier
- Public TitleLaxative therapy in children with functional abdominal pain
- Scientific TitleA randomised controlled trial on the effect of laxative therapy in children with functional abdominal pain
- ACRONYM
- hypothesisBecause of the impact of chronic abdominal pain in children and the long term prognosis with impressive consequences for the life of the patients and for the society, it is important to aim at optimal therapy. Standard therapy is rather ineffective. In an earlier observational study, we had good result with laxative therapy. This needs to be confirmed in a randomised placebo-controlled trial.

Hypothesis 1. In children with functional abdominal pain, laxative therapy leads to a significant reduction of pain.
Hypothesis 2. This effect will be found independent of the presenting Rome IV functional abdominal pain disorder (functional dyspepsia, irritable bowel syndrome or functional abdominal pain-NOS)
- Healt Condition(s) or Problem(s) studiedChronic abdominal pain, Functional abdominal pain, Children
- Inclusion criteria1. 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 criteria1. 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 24-nov-2016
- planned closingdate1-jun-2018
- Target number of participants80
- InterventionsMacrogol 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 consistency with the help of the (adjusted) Bristol Stool Form Scale. The intervention has a total duration of 4 weeks.
- Primary outcomePain score (Wong-Baker Faces Pain Score): % with score 0 (pain free)
- Secondary outcomePain score: % decrease of pain in last week of intervention phase versus last week of run-in phase.
- Timepoints4 weeks and 6 months (follow up)
- Trial web siten.a.
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD PhD Carolien F.M. Gijsbers
- CONTACT for SCIENTIFIC QUERIESMD PhD Carolien F.M. Gijsbers
- Sponsor/Initiator Haga Hospital
- Funding
(Source(s) of Monetary or Material Support)
CZ Fonds
- Publications
- Brief summaryIn a double blind randomised controlled study, children (age 4-16 years) have a 4 week course of the laxative macrogol 4000 versus placebo with the percentage of pain free patients as first outcome measure and the percentage decrease of pain score as second outcome measure.
- Main changes (audit trail)
- RECORD20-nov-2016 - 27-nov-2016


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