Functional Constipation, Fecal Incontinence in Children
Conditions
Keywords
trans anal irrigation, retentive fecal incontinence, low volume TAI
Brief 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.
Detailed 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.
Interventions
To be taken orally on a daily basis throughout the study period (6 weeks) in an adjusted dose.
DEVICELow volume trans anal irrigation
To be administered rectally on a daily basis throughout the study period (6 weeks) along with an adjusted dose of polyethylene glycols
Sponsors
Qufora A/S
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking not possible, since the add-on treatment requires training of parents and children and is a physical device to be handed out
Intervention model description
50 children randomized into 2 groups. Group a receives current standard treatment, group b receives current standard treatment plus low volume trans anal irrigation as add-on.
Eligibility
Sex/Gender
ALL
Age
4 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* age 4-14 years * medical history with fecal incontinence \>1/week on a non-neurogenic but retentive basis (fulfills ROME-IV-criteria) * non-responsive after min. 2 months treatment with polyethylene glycols and behavioral interventions (set times for toilet use)
Exclusion criteria
* Hirschsprungs disease * anorectal malformations * use of medications known to cause constipation (eg. anticholinergics) * former use of low or high volume TAI or enemas Contraindications for use of MiniGo-irrigation device: * known stenosis of the rectum or intestinal tract * colorectal cancer prior to surgical removal * acute inflammatory bowel disease * acute diverticulitis * within 3 months of surgical procedures in the rectum or intestinal tract * within 4 weeks of endoscopic polypectomy * ischemic colitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal incontinence episodes | 6 weeks | Seeks to measure if there is any significant difference in the amount of fecal incontinence episodes between the two groups after the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Well-being | 6 weeks | Seeks to measure if the well-being of the children changes when their symptoms are treated. Measured using the WHO-5-well being index |
| Tolerability of low volume TAI | 6 weeks | Seeks to investigate whether low volume TAI is tolerated by the children, or if the system causes pain or discomfort. |
| Constipation symptoms | 6 weeks | Seeks to investigate whether constipation symptoms (based on ROME-IV criteria) change after treatment |
Countries
Denmark
Outcome results
None listed