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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: * 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.
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.
Age
4 - 14 years
Sex
ALL
Healthy Volunteers
No
Aalborg Universitetshospital
Aalborg, Vælg Provins, Denmark
Aarhus Universitetshospital
Aarhus, Vælg Provins, Denmark
Regionshospitalet Gødstrup
Herning, Vælg Provins, Denmark
Start Date
November 1, 2022
Primary Completion Date
August 20, 2024
Completion Date
August 20, 2024
Last Updated
November 15, 2024
50
ACTUAL participants
Polyethylene Glycols
DRUG
Low volume trans anal irrigation
DEVICE
Lead Sponsor
University of Aarhus
Collaborators
NCT07091084
NCT06196073
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07336589