Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

NCT ID: NCT03981510

Last Updated: 2020-11-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-13
• Study Completion Date: 2023-12-31

Brief 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.

Conditions

Constipation; Childhood Acute Lymphoblastic Leukemia; Neurofibromatosis 1; Chronic Constipation With Overflow

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Children being investigated with 3D-transit

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)

Group Type: EXPERIMENTAL

3D-Transit

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aarhus University Hospital

Aarhus, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Klaus Krogh, Professor, PhD, MD

Role: CONTACT

Phone: +45 23 38 59 37

Email: klaukrog@rm.dk

Facility Contacts

Klaus Krogh, professor, ph.d.

Role: primary

Christian Emil Brinck, medical student

Role: backup

References

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.

Reference Type: DERIVED

PMID: 34091540 (View on PubMed)

Other Identifiers

3D-Transit Children AUH

Identifier Type: -

Identifier Source: org_study_id