Clinical trial NCT05570318: Effect of MiniGo As Add-on to Oral Laxatives for Children with Constipation and Fecal Incontinence
Official title: Effect of MiniGo As Add-on to Oral Laxatives for Children with Constipation and Fecal Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Constipation
Fecal Incontinence in Children
Keywords: trans anal irrigation
retentive fecal incontinence
low volume TAI
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Qufora A/S
First posted: 2022-10-06
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fecal incontinence episodes
timeFrame: 6 weeks
Secondary outcomes:
measure: Well-being
timeFrame: 6 weeks
measure: Tolerability of low volume TAI
timeFrame: 6 weeks
measure: Constipation symptoms
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
state: Vælg provins
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
state: Vælg provins
city: Herning
country: Denmark
facility: Regionshospitalet Gødstrup
state: Vælg provins
Study officials:
References: