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

NCT05570318 | Completed

• 1 other identifier: minigo
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Functional Constipation; Fecal Incontinence in Children

Keywords

trans anal irrigation; retentive fecal incontinence; low volume TAI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Well-being

  6 weeks

• Tolerability of low volume TAI

  6 weeks

• Constipation symptoms

  6 weeks

Study Arms (2)

Polyethylene glycols

ACTIVE COMPARATOR

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

Drug: Polyethylene Glycols

Polyethylene glycols and low volume trans anal irrigation

EXPERIMENTAL

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.

Drug: Polyethylene Glycols; Device: Low volume trans anal irrigation

Interventions

Polyethylene Glycols DRUG

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

Polyethylene glycols; Polyethylene glycols and low volume trans anal irrigation

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

Polyethylene glycols and low volume trans anal irrigation

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Qufora A/S: collaborator

Study Sites (3)

Aalborg Universitetshospital

Aalborg, Vælg Provins, 9000, Denmark

Location

Aarhus Universitetshospital

Aarhus, Vælg Provins, 8200, Denmark

Location

Regionshospitalet Gødstrup

Herning, Vælg Provins, 7400, Denmark

Location

Related Publications (1)

• Larsen SO, Axelgaard S, Jonsson IM, Brodersen B, Kristensen SB, Nielsen BR, Hagstrom S, Borch L. Efficacy of low volume transanal irrigation in children with retentive fecal incontinence: A randomized controlled trial. J Pediatr Gastroenterol Nutr. 2025 Nov 18. doi: 10.1002/jpn3.70279. Online ahead of print.

  PMID: 41250992 DERIVED

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking not possible, since the add-on treatment requires training of parents and children and is a physical device to be handed out
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 6, 2022
• Study Start: November 1, 2022
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)