Clinical trial · Interventional
Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation
NCT03981510CI-TRIAL-00048496unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Constipation With Overflow | — | UNRESOLVED | — |
| Constipation | — | UNRESOLVED | — |
| Neurofibromatosis 1 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D-Transit | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 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)
- interventionNames
- Diagnostic Test: 3D-Transit
Primary outcomes (4)
- measure
- The investigation is without discomfort and adverse events.
- timeFrame
- 3 days
- measure
- Children with chronic constipation has a longer transit time through the colon and fewer fast bowel movements than healthy children.
- timeFrame
- 3 days
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBrinck 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. PMID 34091540