Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

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Brief Title

Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

Official Title

Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

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.
    



Study Type

Interventional


Primary Outcome

The investigation is without discomfort and adverse events.


Condition

Constipation

Intervention

3D-Transit

Study Arms / Comparison Groups

 Children being investigated with 3D-transit
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)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

80

Start Date

June 13, 2019

Completion Date

December 2023

Primary Completion Date

December 2023

Eligibility 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
      

Gender

All

Ages

7 Years - 17 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, +45 23 38 59 37, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT03981510

Organization ID

3D-Transit Children AUH


Responsible Party

Sponsor

Study Sponsor

University of Aarhus


Study Sponsor

, , 


Verification Date

September 2020