Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

NCT03981510 | Unknown DMC

• 1 other identifier: 3D-Transit Children AUH
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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)

Diagnostic Test: 3D-Transit

Interventions

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.

Children being investigated with 3D-transit

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 34091540 DERIVED

MeSH Terms

Conditions

Constipation; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neurofibromatosis 1

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Klaus Krogh, Professor, PhD, MD

CONTACT

+45 23 38 59 37; klaukrog@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 10, 2019
• Study Start: June 13, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 25, 2020

Record last verified: 2020-09

Locations

DK (1)