Laxative therapy in children with functional abdominal pain

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.

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)

4 weeks and 6 months (follow up)

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.