Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

Not Applicable

• Conditions: Neurofibromatosis 1; Chronic Constipation With Overflow; Childhood Acute Lymphoblastic Leukemia; Constipation
• Interventions: Diagnostic Test: 3D-Transit

• Registration Number: NCT03981510
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-10
• Study Start: 2019-06-13
• Status Verified: 2020-09
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-25
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children being investigated with 3D-transit	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)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark