Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

Constipation Clinical Trial

Official title:

Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03981510
• Other study ID #: 3D-Transit Children AUH
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2019
• Est. completion date: December 2023

Study information

• Verified date: September 2020
• Source: University of Aarhus
• Contact: Klaus Krogh, Professor, PhD, MD
• Phone: +45 23 38 59 37
• Email: klaukrog[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Acute Lymphoblastic Leukemia
• Chronic Constipation With Overflow
• Constipation
• Neurofibromatoses
• Neurofibromatosis 1
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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