Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

November 23, 2020 updated by: University of Aarhus
To gain a better understanding of the underlying dysmotility in constipation in children, we will use a novel minimal invasive method called 3D Transit. We will examine four groups of children aged 7 to 17 years: healthy children, chronically constipated children (ROM IV criteria), children with neurofibromatosis type 1 and finally children receiving chemotherapy (vincristin) for acute lymphoblastic leukemia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Klaus Krogh, Professor, PhD, MD
  • Phone Number: +45 23 38 59 37
  • Email: klaukrog@rm.dk

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Klaus Krogh, professor, ph.d.
          • Phone Number: +45 23 38 59 37‬
          • Email: klaukrog@rm.dk
        • Contact:
          • Christian Emil Brinck, medical student
          • Phone Number: +45 27110447
          • Email: ceb@clin.au.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria applicable to all participants:

• Children between 7-17 years of age where permission is granted for the participation by habitable parents with custody of the child. In case of joint custody, permission must be obtained from both parents.

Inclusion criteria applicable only to healthy participants:

• Gastrointestinal healthy children without chronic constipation

Inclusion criteria applicable only to constipated participants:

• Chronic constipation defined by Rom IV criteria, which is a diagnostic score for chronic constipation

Inclusion criteria applicable only to children in vincristine treatment:

• Children with cancer in treatment with vincristine

Inclusion criteria applicable only to patients with NF1:

• Diagnosis of NF1 with gastrointestinal symptoms

Exclusion Criteria:

  • Children with parents who are unable to understand the given particpant's information
  • Children with known dysregulated metabolic disease
  • Previously major intra-abdominal surgery
  • CNS surgery
  • Other treatment-requiring gastrointestinal disorder
  • Systemic steroid treatment within the last week
  • Children with difficulty swallowing
  • Children with known gastrointestinal obstruction or perforation
  • Acute infections
  • Diagnosed malabsorption including bile acid malabsorption
  • Menarche in girls

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children being investigated with 3D-transit

4 groups of each 20 children will be investigated with respectively one or two capsules:

  • Healthy children (1)
  • Children with chronic constipation (2)
  • Children with neurofibromatosis type 1 (2)
  • Children with cancer receiving treatment with Vincristine (1)
Diagnostic test: 3D-Transit
3D transit investigation consists of a small electromagnetic pill and a detector located in a belt around the waist. The pill is swallowed by the participant and the belt is worn until the pill has left the gastrointestinal tract. The method is without any pain and discomfort for the child. The child will visit the hospital the first time to ingest the capsule alongside a standardized meal, and is then free to go home and proceed with daily activities (beside hard exersize) while wearing the belt with the detector. The next day, the child will again visit the hospital to check whether or not the capsule has left the tract - this is done with a computer and software. The children ingesting two capsules will do this with a certain delay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The investigation is without discomfort and adverse events.
Time Frame: 3 days
3 days
Children with chronic constipation has a longer transit time through the colon and fewer fast bowel movements than healthy children.
Time Frame: 3 days
3 days
Children in Vincristine treatment has a longer transit time through the colon and fewer fast bowel movements than healthy children.
Time Frame: 3 days
3 days
Children with NF1 and gastrointestinal symptoms has a longer transit time through the colon and fewer fast bowel movements than healthy children.
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2019

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

June 7, 2019

First Submitted That Met QC Criteria

June 7, 2019

First Posted (Actual)

June 10, 2019

Study Record Updates

Last Update Posted (Actual)

November 25, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3D-Transit Children AUH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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