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| Name | Class |
|---|---|
| Qufora A/S | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyethylene glycols | Active Comparator | This group consists of children who have already been treated with oral laxatives (PEG) for at least 2 months, but still experience symptoms of constipation and fecal incontinence. Their PEG dosage will be adjusted to the ideal dose for the individual child (this will be evaluated by a health care professional), with the minimum dosage being the maintenance dose of 0,5mg/kg/day, and the maximum dosage being the disimpaction dose of 1,5mg/kg/day |
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| Polyethylene glycols and low volume trans anal irrigation | Experimental | This group consists of children who have already been treated with oral laxatives (PEG) for at least 2 months, but still experience symptoms of constipation and fecal incontinence. PEG dose will be adjusted in the same manner as in group a, but this group will also receive daily treatment with low volume trans anal irrigation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene Glycols | Drug | To be taken orally on a daily basis throughout the study period (6 weeks) in an adjusted dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fecal incontinence episodes | Seeks to measure if there is any significant difference in the amount of fecal incontinence episodes between the two groups after the study period | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Well-being | Seeks to measure if the well-being of the children changes when their symptoms are treated. Measured using the WHO-5-well being index | 6 weeks |
| Tolerability of low volume TAI | Seeks to investigate whether low volume TAI is tolerated by the children, or if the system causes pain or discomfort. |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications for use of MiniGo-irrigation device:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Universitetshospital | Aalborg | Vælg Provins | 9000 | Denmark | ||
| Aarhus Universitetshospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41250992 | Derived | 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. |
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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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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.
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Masking not possible, since the add-on treatment requires training of parents and children and is a physical device to be handed out
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| Low volume trans anal irrigation | Device | To be administered rectally on a daily basis throughout the study period (6 weeks) along with an adjusted dose of polyethylene glycols |
|
| 6 weeks |
| Constipation symptoms | Seeks to investigate whether constipation symptoms (based on ROME-IV criteria) change after treatment | 6 weeks |
| Aarhus |
| Vælg Provins |
| 8200 |
| Denmark |
| Regionshospitalet Gødstrup | Herning | Vælg Provins | 7400 | Denmark |
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |