Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT05570318
Status:
COMPLETED
Last Update Posted:
2024-11-15
First Post:
2022-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of MiniGo As Add-on to Oral Laxatives for Children with Constipation and Fecal Incontinence
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
Effect of MiniGo As Add-on to Oral Laxatives for Children with Constipation and Fecal Incontinence
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: