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出境医 / 临床实验 / Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

Study Description
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.

Condition or disease Intervention/treatment Phase
Constipation Childhood Acute Lymphoblastic Leukemia Neurofibromatosis 1 Chronic Constipation With Overflow Diagnostic Test: 3D-Transit Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: 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)
 Diagnostic Test: 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.
Outcome Measures
Primary Outcome Measures :
  1. The investigation is without discomfort and adverse events. [ Time Frame: 3 days ]
  2. Children with chronic constipation has a longer transit time through the colon and fewer fast bowel movements than healthy children. [ Time Frame: 3 days ]
  3. Children in Vincristine treatment has a longer transit time through the colon and fewer fast bowel movements than healthy children. [ Time Frame: 3 days ]
  4. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Contacts
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Contact: Klaus Krogh, Professor, PhD, MD +45 23 38 59 37 klaukrog@rm.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Klaus Krogh, professor, ph.d.    +45 23 38 59 37‬    klaukrog@rm.dk   
Contact: Christian Emil Brinck, medical student    +45 27110447    ceb@clin.au.dk   
Sponsors and Collaborators
University of Aarhus
Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date November 25, 2020
Actual Study Start Date  ICMJE June 13, 2019
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Constipation
  • Childhood Acute Lymphoblastic Leukemia
  • Neurofibromatosis 1
  • Chronic Constipation With Overflow
Intervention  ICMJE Diagnostic Test: 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.
Study Arms  ICMJE Experimental: 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)
Intervention: Diagnostic Test: 3D-Transit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2019) 		80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Klaus Krogh, Professor, PhD, MD +45 23 38 59 37 klaukrog@rm.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03981510
Other Study ID Numbers  ICMJE 3D-Transit Children AUH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Aarhus
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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