Because 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…
ID
Bron
Aandoening
Functional abdominal pain. Chronic abdominal pain. Children. Laxatives. Rome criteria.
Ondersteuning
Els Borst-Eilersplein 275, 2545 AA The Hague
Tilburg
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Pain score (Wong-Baker Faces Pain Score): % with score 0 (pain free)
Achtergrond van het onderzoek
In 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.
Doel van het onderzoek
Because 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)
Onderzoeksopzet
4 weeks and 6 months (follow up)
Onderzoeksproduct en/of interventie
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 consistency with the help of the (adjusted) Bristol Stool Form Scale. The intervention has a total duration of 4 weeks.
Publiek
Carolien F.M. Gijsbers
Den Haag 2517 TE
The Netherlands
+31.(0)70 3463443
cfm.gijsbers@planet.nl
Wetenschappelijk
Carolien F.M. Gijsbers
Den Haag 2517 TE
The Netherlands
+31.(0)70 3463443
cfm.gijsbers@planet.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL5930 |
NTR-old | NTR6110 |
Ander register | EudraCT, ABR dossier : 2014-005467-32, NL57969.098.16 |