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Completed

NCT Number: NCT05570318

Effect of MiniGo As Add-on to Oral Laxatives for Children with Constipation and Fecal Incontinence

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.

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Key information

Conditions

Functional Constipation Fecal Incontinence in Children

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg Universitetshospital, Aalborg, Vælg Provins, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyethylene Glycols

Drug

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

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

Primary outcomes

  1. Fecal incontinence episodes

    Time frame: 6 weeks

    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 outcomes

  1. Well-being

    Time frame: 6 weeks

    Seeks to measure if the well-being of the children changes when their symptoms are treated. Measured using the WHO-5-well being index

  2. Tolerability of low volume TAI

    Time frame: 6 weeks

    Seeks to investigate whether low volume TAI is tolerated by the children, or if the system causes pain or discomfort.

  3. Constipation symptoms

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Qufora A/S

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 6, 2022
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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