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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 1, 2023

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Polyethylene glycols
    • 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
  • Experimental: Polyethylene glycols and low volume trans anal irrigation
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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.
  • Constipation symptoms
    • Time Frame: 6 weeks
    • Seeks to investigate whether constipation symptoms (based on ROME-IV criteria) change after treatment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 14 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Aarhus
  • Collaborator
    • Qufora A/S
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Luise Borch, MD, phd, +4578430389, luise.borch@rm.dk

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