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Effect of MiniGo as add-on to Oral Laxatives for Children With Constipation and Fecal Incontinence

Primary Purpose

Functional Constipation, Fecal Incontinence in Children

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Polyethylene Glycols
Low volume trans anal irrigation
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Constipation focused on measuring trans anal irrigation, retentive fecal incontinence, low volume TAI

Eligibility Criteria

4 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aalborg UniversitetshospitalRecruiting
  • Aarhus UniversitetshospitalRecruiting
  • Regionshospitalet GødstrupRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Polyethylene glycols

Polyethylene glycols and low volume trans anal irrigation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
Constipation symptoms
Seeks to investigate whether constipation symptoms (based on ROME-IV criteria) change after treatment

Full Information

First Posted
October 5, 2022
Last Updated
May 9, 2023
Sponsor
University of Aarhus
Collaborators
Qufora A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05570318
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Qufora A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation, Fecal Incontinence in Children
Keywords
trans anal irrigation, retentive fecal incontinence, low volume TAI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
Masking not possible, since the add-on treatment requires training of parents and children and is a physical device to be handed out
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Polyethylene glycols
Arm Type
Active Comparator
Arm Description
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
Arm Title
Polyethylene glycols and low volume trans anal irrigation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Polyethylene Glycols
Intervention Description
To be taken orally on a daily basis throughout the study period (6 weeks) in an adjusted dose.
Intervention Type
Device
Intervention Name(s)
Low volume trans anal irrigation
Intervention Description
To be administered rectally on a daily basis throughout the study period (6 weeks) along with an adjusted dose of polyethylene glycols
Primary Outcome Measure Information:
Title
Fecal incontinence episodes
Description
Seeks to measure if there is any significant difference in the amount of fecal incontinence episodes between the two groups after the study period
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Well-being
Description
Seeks to measure if the well-being of the children changes when their symptoms are treated. Measured using the WHO-5-well being index
Time Frame
6 weeks
Title
Tolerability of low volume TAI
Description
Seeks to investigate whether low volume TAI is tolerated by the children, or if the system causes pain or discomfort.
Time Frame
6 weeks
Title
Constipation symptoms
Description
Seeks to investigate whether constipation symptoms (based on ROME-IV criteria) change after treatment
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luise Borch, MD, phd
Phone
+4578430389
Email
luise.borch@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Signe Ø Larsen, BSc
Phone
+4527519605
Email
sielrs@rm.dk
Facility Information:
Facility Name
Aalborg Universitetshospital
City
Aalborg
State/Province
Vælg Provins
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Signe Øbo Larsen, BSc
Phone
+4527519605
Email
sielrs@rm.dk
Facility Name
Aarhus Universitetshospital
City
Aarhus
State/Province
Vælg Provins
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Signe Øbo Larsen, BSc
Phone
+4527519605
Email
sielrs@rm.dk
Facility Name
Regionshospitalet Gødstrup
City
Herning
State/Province
Vælg Provins
ZIP/Postal Code
7400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Signe Øbo Larsen, BSc
Phone
27519605
Email
sielrs@rm.dk
First Name & Middle Initial & Last Name & Degree
Luise Borch, MD, phd
Phone
22925502
Email
luise.borch@rm.dk

12. IPD Sharing Statement

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Effect of MiniGo as add-on to Oral Laxatives for Children With Constipation and Fecal Incontinence

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