Functional ConstipationNCT05570318
Effect of MiniGo As Add-on to Oral Laxatives for Children with Constipation and Fecal Incontinence
A study testing Polyethylene Glycols and Low volume trans anal irrigation in people with Functional Constipation and Fecal Incontinence in Children, run by University of Aarhus at 3 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Functional Constipation, Fecal Incontinence in Children
- What is being tested?
- Polyethylene Glycols and Low volume trans anal irrigation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Nov 2022to 20 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aalborg Universitetshospital
Aalborg, Vælg Provins, 9000
Aarhus Universitetshospital
Aarhus, Vælg Provins, 8200
Regionshospitalet Gødstrup
Herning, Vælg Provins, 7400
About this study
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:
Read more
- 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.
Read the 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.
- Being tested
- Polyethylene Glycols, Low volume trans anal irrigation
- Keywords
- trans anal irrigation, retentive fecal incontinence, low volume TAI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene GlycolsDrug
To be taken orally on a daily basis throughout the study period (6 weeks) in an adjusted dose.
Low volume trans anal irrigationDevice
To be administered rectally on a daily basis throughout the study period (6 weeks) along with an adjusted dose of polyethylene glycols
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Polyethylene Glycols; Device: Low volume trans anal irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (3)
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
Measured: 6 weeks
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.
Measured: 6 weeks
Constipation symptoms
Seeks to investigate whether constipation symptoms (based on ROME-IV criteria) change after treatment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Nov 2022
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Qufora A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570318
- Sponsor's protocol ID
- minigo
- Status last verified
- Nov 2024
- First submitted
- 5 Oct 2022
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Feb;82(2):425-433. doi: 10.1002/jpn3.70279. Epub 2025 Nov 18.
PubMed 41250992
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of MiniGo As Add-on to Oral Laxatives for Children with Constipation and Fecal Incontinence
- ClinicalTrials.gov ID
- NCT05570318
- Acronym / sponsor ID
- minigo
- Keywords
- trans anal irrigation, retentive fecal incontinence, low volume TAI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Qufora A/S
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Polyethylene glycols | Active comparator | Drug: Polyethylene GlycolsThis 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 |
| Polyethylene glycols and low volume trans anal irrigation | Experimental | Drug: Polyethylene Glycols, Device: Low volume trans anal irrigationThis 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. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- Hirschsprungs disease
- anorectal malformations
- use of medications known to cause constipation (eg. anticholinergics)
- former use of low or high volume TAI or enemas
- known stenosis of the rectum or intestinal tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyethylene GlycolsTo be taken orally on a daily basis throughout the study period (6 weeks) in an adjusted dose. | Drug | Polyethylene glycols, Polyethylene glycols and low volume trans anal irrigation |
| Low volume trans anal irrigationTo be administered rectally on a daily basis throughout the study period (6 weeks) along with an adjusted dose of polyethylene glycols | Device | Polyethylene glycols and low volume trans anal irrigation |
Primary outcome
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
3 secondary outcomes
Well-being
Time frame: 6 weeks
Tolerability of low volume TAI
Time frame: 6 weeks
Constipation symptoms
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Derived from this study: PubMed 41250992Larsen 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. 2026 Feb;82(2):425-433. doi: 10.1002/jpn3.70279. Epub 2025 Nov 18.
- Individual participant dataSharing planned: No
Related trials for Functional Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyethylene Glycols and Low volume trans anal irrigation in people with Functional Constipation and Fecal Incontinence in Children, run by University of Aarhus at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal incontinence episodes (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05570318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.