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Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

Primary Purpose

Constipation, Childhood Acute Lymphoblastic Leukemia, Neurofibromatosis 1

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
3D-Transit
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Constipation

Eligibility Criteria

7 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Children being investigated with 3D-transit

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 7, 2019
Last Updated
November 23, 2020
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT03981510
Brief Title
Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation
Official Title
Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Childhood Acute Lymphoblastic Leukemia, Neurofibromatosis 1, Chronic Constipation With Overflow

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children being investigated with 3D-transit
Arm Type
Experimental
Arm Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
3D-Transit
Intervention Description
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.
Primary Outcome Measure Information:
Title
The investigation is without discomfort and adverse events.
Time Frame
3 days
Title
Children with chronic constipation has a longer transit time through the colon and fewer fast bowel movements than healthy children.
Time Frame
3 days
Title
Children in Vincristine treatment has a longer transit time through the colon and fewer fast bowel movements than healthy children.
Time Frame
3 days
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Klaus Krogh, Professor, PhD, MD
Phone
+45 23 38 59 37
Email
klaukrog@rm.dk
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus Krogh, professor, ph.d.
Phone
+45 23 38 59 37‬
Email
klaukrog@rm.dk
First Name & Middle Initial & Last Name & Degree
Christian Emil Brinck, medical student
Phone
+45 27110447
Email
ceb@clin.au.dk

12. IPD Sharing Statement

Citations:
PubMed Identifier
34091540
Citation
Brinck CE, Mark EB, Ejerskov C, Johansen KB, Sutter N, Schlageter V, Drewes AM, Krogh K. Regional Gastrointestinal Motility in Healthy Children. J Pediatr Gastroenterol Nutr. 2021 Sep 1;73(3):306-313. doi: 10.1097/MPG.0000000000003198.
Results Reference
derived

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Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

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