Effect of MiniGo As Add-on to Oral Laxatives for Children with Constipation and Fecal Incontinence

Summary

The goal of this clinical trial is to compare combination therapy with low volume trans anal irrigation (TAI) and oral laxatives to monotherapy with oral laxatives in children with functional constipation and fecal incontinence. The main questions it aims to answer are: * Can more efficient treatment be achieved with aforementioned combination therapy? * Does the well-being of the children change, when they are well treated for their symptoms? * Is low-volume trans anal irrigation a tolerable treatment method for children? Participants will be randomized into 2 groups, where one group is treated with current standard treatment of PEG (oral laxatives), and the other group is treated with PEG + daily low volume TAI.

Timeline

Start

2022-11-01

Primary completion

2024-08-20

Completion

2024-08-20

Publications

• Larsen SO, Axelgaard S, Jonsson IM, Brodersen B, Kristensen SB, Nielsen BR, Hagstrom S, Borch L. Efficacy of low volume transanal irrigation in children with retentive fecal incontinence: A randomized controlled trial. J Pediatr Gastroenterol Nutr. 2026 Feb;82(2):425-433. doi: 10.1002/jpn3.70279. Epub 2025 Nov 18.

Drugs

Indications