Status
Conditions
Treatments
About
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:
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.
Full description
Functional constipation and retentive fecal incontinence is a prevalent health issue in children. The current standard treatment regimen in Denmark consists mainly of behavioral interventions and oral laxative treatment. This treatment leaves a large group of non-responders. Suffering from constipation and fecal incontinence has a negative impact on well-being in children, wherefore treatment of this condition should be improved.
Earlier literature shows that trans anal irrigation (TAI) is an effective means of managing these symptoms, both in children and adults. However, conventional high volume TAI is time consuming (up to 45 minutes-an hour daily) and a cause of discomfort, or even pain. This can lead to low compliance and treatment failure.
Low volume TAI has the potential of bringing about all the positive effects of TAI, but with less time consumption (only few minutes daily) and less discomfort.
In this clinical trial, we will compare how children with functional constipation and fecal incontinence respond to treatment with 1) oral laxatives (PEG) alone versus 2) PEG and low volume TAI with the MiniGo-irrigation system.
The intervention period is 6 weeks, and the treatment takes place at home.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Contraindications for use of MiniGo-irrigation device:
Primary purpose
Allocation
Interventional model
Masking
50 participants in 2 patient groups
Loading...
Central trial contact
Signe Ø Larsen, BSc; Luise Borch, MD, phd
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal