NCT03981510

Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Constipation
• Childhood Acute Lymphoblastic Leukemia
• Neurofibromatosis 1
• Chronic Constipation With Overflow

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-13
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2019-06-10
• Last updated: 2020-11-25

Locations

1 site across 1 country: Denmark