Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Aarhus
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- The investigation is without discomfort and adverse events.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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)
Intervention: 3D-Transit (Diagnostic Test)
Outcomes
Primary Outcomes
The investigation is without discomfort and adverse events.
Time Frame: 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
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
Children with chronic constipation has a longer transit time through the colon and fewer fast bowel movements than healthy children.
Time Frame: 3 days
Secondary Outcomes
No secondary outcomes reported