Effect of MiniGo As Add-on to Oral Laxatives for Children with Constipation and Fecal Incontinence (NCT05570318) | Clinical Trial Compass
CompletedNot Applicable
Effect of MiniGo As Add-on to Oral Laxatives for Children with Constipation and Fecal Incontinence
Denmark50 participantsStarted 2022-11-01
Plain-language 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.
Who can participate
Age range
4 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.