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

NCT05570318 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-11-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Qufora A/S

    collaborator INDUSTRY

  • University of Aarhus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2024-08-20
Completion
2024-08-20

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05570318 on ClinicalTrials.gov