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
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 Type
Interventional
Primary Outcome
The investigation is without discomfort and adverse events.
Condition
Constipation
Intervention
3D-Transit
Study Arms / Comparison Groups
Children being investigated with 3D-transit
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)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
80
Start Date
June 13, 2019
Completion Date
December 2023
Primary Completion Date
December 2023
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
Gender
All
Ages
7 Years - 17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
, +45 23 38 59 37, [email protected]
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT03981510
Organization ID
3D-Transit Children AUH
Responsible Party
Sponsor
Study Sponsor
University of Aarhus
Study Sponsor
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Verification Date
September 2020