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

Functional Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05570318
• Other study ID #: minigo
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: October 2022
• Source: University of Aarhus
• Contact: Luise Borch, MD, phd
• Phone: +4578430389
• Email: luise.borch[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Fecal Incontinence
• Fecal Incontinence in Children
• Functional Constipation

Intervention

Drug:
• Polyethylene Glycols
To be taken orally on a daily basis throughout the study period (6 weeks) in an adjusted dose.

Device:
• Low volume trans anal irrigation
To be administered rectally on a daily basis throughout the study period (6 weeks) along with an adjusted dose of polyethylene glycols

Locations

Country	Name	City	State
Denmark	Aalborg Universitetshospital	Aalborg	Vælg Provins
Denmark	Aarhus Universitetshospital	Aarhus	Vælg Provins
Denmark	Regionshospitalet Gødstrup	Herning	Vælg Provins

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Qufora A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	6 weeks
Secondary	Constipation symptoms	Seeks to investigate whether constipation symptoms (based on ROME-IV criteria) change after treatment	6 weeks