Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation (NCT03981510) | Clinical Trial Compass
UnknownNot Applicable
Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation
Denmark80 participantsStarted 2019-06-13
Plain-language 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.
Who can participate
Age range
7 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The investigation is without discomfort and adverse events.
Timeframe: 3 days
2
Children with chronic constipation has a longer transit time through the colon and fewer fast bowel movements than healthy children.
Timeframe: 3 days
3
Children in Vincristine treatment has a longer transit time through the colon and fewer fast bowel movements than healthy children.
Timeframe: 3 days
4
Children with NF1 and gastrointestinal symptoms has a longer transit time through the colon and fewer fast bowel movements than healthy children.