Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

University of Aarhus

Status: Unknown

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

Treatments: Diagnostic Test: 3D-Transit

Study type: Interventional

Funder types: Other

Identifiers

NCT03981510

3D-Transit Children AUH

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Children being investigated with 3D-transit

Experimental group

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)

Treatment:

Diagnostic Test: 3D-Transit