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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children being investigated with 3D-transit | Experimental | 4 groups of each 20 children will be investigated with respectively one or two capsules:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D-Transit | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The investigation is without discomfort and adverse events. | 3 days | |
| Children with chronic constipation has a longer transit time through the colon and fewer fast bowel movements than healthy children. | 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 |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Klaus Krogh, Professor, PhD, MD | Contact | +45 23 38 59 37 | klaukrog@rm.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34091540 | Derived | Brinck CE, Mark EB, Ejerskov C, Johansen KB, Sutter N, Schlageter V, Drewes AM, Krogh K. Regional Gastrointestinal Motility in Healthy Children. J Pediatr Gastroenterol Nutr. 2021 Sep 1;73(3):306-313. doi: 10.1097/MPG.0000000000003198. |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009456 | Neurofibromatosis 1 |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
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|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D017253 | Neurofibromatoses |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009386 | Neoplastic Syndromes, Hereditary |
| D020752 | Neurocutaneous Syndromes |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |