ConstipationNCT03981510
Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation
A study testing 3D-Transit in people with Constipation and Childhood Acute Lymphoblastic Leukemia, run by University of Aarhus at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation, Childhood Acute Lymphoblastic Leukemia, Neurofibromatosis 1
- What is being tested?
- 3D-Transit
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Jun 2019to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
- 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
- Diagnosis of NF1 with gastrointestinal symptoms
Who cannot join
- 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
Show all 11Show fewer
- Children with difficulty swallowing
- Children with known gastrointestinal obstruction or perforation
- Acute infections
- Diagnosed malabsorption including bile acid malabsorption
- Menarche in girls
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Klaus Krogh, professor, ph.d., +45 23 38 59 37, klaukrog@rm.dk
Christian Emil Brinck, medical student, +45 27110447, ceb@clin.au.dk
About this study
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
- Constipation, Childhood Acute Lymphoblastic Leukemia, Neurofibromatosis 1, Chronic Constipation With Overflow
- Being tested
- 3D-Transit
- Medical subject headings
- Constipation, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neurofibromatosis 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-TransitDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Children being investigated with 3D-transit | Experimental | 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) Receives: Diagnostic Test: 3D-Transit |
What is being measured
The primary outcome is the main question the study is designed to answer.
The investigation is without discomfort and adverse events.
Measured: 3 days
Children with chronic constipation has a longer transit time through the colon and fewer fast bowel movements than healthy children.
Measured: 3 days
Children in Vincristine treatment has a longer transit time through the colon and fewer fast bowel movements than healthy children.
Measured: 3 days
Children with NF1 and gastrointestinal symptoms has a longer transit time through the colon and fewer fast bowel movements than healthy children.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start13 Jun 2019
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981510
- Sponsor's protocol ID
- 3D-Transit Children AUH
- Status last verified
- Sep 2020
- First submitted
- 7 Jun 2019
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34091540
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation
- ClinicalTrials.gov ID
- NCT03981510
- Acronym / sponsor ID
- 3D-Transit Children AUH
- Conditions
- Constipation, Childhood Acute Lymphoblastic Leukemia, Neurofibromatosis 1, Chronic Constipation With Overflow
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children being investigated with 3D-transit | Experimental | Diagnostic Test: 3D-Transit4 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) |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
- Gastrointestinal healthy children without chronic constipation
- Chronic constipation defined by Rom IV criteria, which is a diagnostic score for chronic constipation
- Children with cancer in treatment with vincristine
- Diagnosis of NF1 with gastrointestinal symptoms
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-Transit3D 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. | Diagnostic test | Children being investigated with 3D-transit |
Primary outcome
The investigation is without discomfort and adverse events.
Time frame: 3 days
Children with chronic constipation has a longer transit time through the colon and fewer fast bowel movements than healthy children.
Time frame: 3 days
Children in Vincristine treatment has a longer transit time through the colon and fewer fast bowel movements than healthy children.
Time frame: 3 days
Children with NF1 and gastrointestinal symptoms has a longer transit time through the colon and fewer fast bowel movements than healthy children.
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Derived from this study: PubMed 34091540Brinck 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.
Related trials for Constipation
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-Transit in people with Constipation and Childhood Acute Lymphoblastic Leukemia, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Klaus Krogh, Professor, PhD, MD (+45 23 38 59 37, klaukrog@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The investigation is without discomfort and adverse events. (time frame: 3 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03981510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.