Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03981510
Other study ID # 3D-Transit Children AUH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 13, 2019
Est. completion date December 2023

Study information

Verified date September 2020
Source University of Aarhus
Contact Klaus Krogh, Professor, PhD, MD
Phone +45 23 38 59 37
Email klaukrog@rm.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
3D-Transit
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.

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary The investigation is without discomfort and adverse events. 3 days
Primary Children with chronic constipation has a longer transit time through the colon and fewer fast bowel movements than healthy children. 3 days
Primary Children in Vincristine treatment has a longer transit time through the colon and fewer fast bowel movements than healthy children. 3 days
Primary Children with NF1 and gastrointestinal symptoms has a longer transit time through the colon and fewer fast bowel movements than healthy children. 3 days
See also
  Status Clinical Trial Phase
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Recruiting NCT06292949 - Clinical Study of Resistant Starch in Improving Constipation N/A
Recruiting NCT04132661 - MRI Assessment of Mode of Action of Bisacodyl, Single Dose Phase 4
Terminated NCT02839889 - Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation) Phase 4
Completed NCT02726295 - The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study Phase 4
Recruiting NCT02255747 - Anal Dilatation for Infants and Children With Constipation N/A
Completed NCT02246647 - Biomarkers for Intestinal Permeability in Patients With Constipation
Completed NCT01566409 - Maintenance Treatment for Children With Constipation N/A
Completed NCT02658201 - Ultrafast MRI Imaging to Exclude Constipation N/A
Completed NCT01695915 - Diurnal Variation in Rectal Diameter N/A
Completed NCT01710579 - Normal Values in Ano-rectal 3D High Resolution Manometry N/A
Completed NCT02863848 - Effect of Inulin-type Fructans on Constipated Children. N/A
Completed NCT01411501 - Efficacy and Safety of Acupuncture for Functional Constipation Phase 3
Completed NCT01474499 - A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation Phase 3
Completed NCT01438567 - A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy Phase 3
Completed NCT01170039 - The Effectiveness of Lubiprostone in Constipated Diabetics Phase 4
Completed NCT00931853 - Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC). Phase 3
Active, not recruiting NCT02442115 - Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
Terminated NCT01003249 - Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen Phase 4
Completed NCT00994851 - Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment. Phase 3