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Non-invasive Assessment of Colonic Motility (non-CoMoti)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04624334
Recruitment Status : Terminated (Money issues)
First Posted : November 10, 2020
Last Update Posted : May 19, 2022
Sponsor:
Information provided by (Responsible Party):
Radboud University Medical Center

Brief Summary:

The current diagnostic process of colonic motility disorders often takes a long time and involves multiple invasive, painful and/or unnecessary diagnostic procedures. To improve this diagnostic process, the potential of Electro-Entero-Graphy (EEnG) is investigated.

During the EEnG procedure, several surface electrodes are positioned (under ultrasound guidance) on the abdomen so that electrical activity originating in the colon can be measured. Measurements will be performed after a period of fasting (when the colon is 'silent') and just after a meal (when the colon is moving) in both participants suffering from colonic motility disorders and healthy controls.

It is hypothesized that these measurements are an indication of colonic motility and can be used as a diagnostic tool for colonic motility disorders. It is also hypothesized that this EEnG procedure is not more burdensome than the Gold Standard procedures for diagnosing colonic motility disorders. This will be assessed using questionnaires.


Condition or disease Intervention/treatment
Colon Disease Functional Constipation Electroenterography Slow Transit Hirschsprung Disease Other: Elektro-Entero-Graphy procedure Other: EEnG Questionnaire Other: Gold Standard Questionnaire

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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Electro-Entero-Graphy (EEnG) for Non-invasive Diagnosis of Motility Disorders of the Bowel
Actual Study Start Date : February 25, 2021
Actual Primary Completion Date : May 12, 2022
Actual Study Completion Date : May 12, 2022


Group/Cohort Intervention/treatment
Children with motility disorder Other: Elektro-Entero-Graphy procedure
Fasting, after which pre- and postprandial EEnG measurements are performed.

Other: EEnG Questionnaire
Filling out questionnaire about EEnG procedure.

Other: Gold Standard Questionnaire
Filling out questionnaire about Gold Standard diagnostic used to diagnose colonic motility disorder.

Healthy children Other: Elektro-Entero-Graphy procedure
Fasting, after which pre- and postprandial EEnG measurements are performed.

Other: EEnG Questionnaire
Filling out questionnaire about EEnG procedure.

Adults with motility disorder Other: Elektro-Entero-Graphy procedure
Fasting, after which pre- and postprandial EEnG measurements are performed.

Other: EEnG Questionnaire
Filling out questionnaire about EEnG procedure.

Other: Gold Standard Questionnaire
Filling out questionnaire about Gold Standard diagnostic used to diagnose colonic motility disorder.

Healthy adults Other: Elektro-Entero-Graphy procedure
Fasting, after which pre- and postprandial EEnG measurements are performed.

Other: EEnG Questionnaire
Filling out questionnaire about EEnG procedure.




Primary Outcome Measures :
  1. Power Percent Difference [ Time Frame: During EEnG procedure ]
    Relative power change when comparing pre-prandial EEnG measurements to post-prandial measurements. Power will be calculated as the mean amplitude (mV^2/Hz) in a bandwidth of 2 cycles per minute around the dominant frequency related to colonic movements (between 2-10 cycles per minute).


Secondary Outcome Measures :
  1. EEnG questionnaire score [ Time Frame: Directly after EEnG procedure, which is a one time procedure the subjects in this study will undergo ]
    Burden score of EEnG procedure as assessed by a self created questionnaire (in collaboration with medical doctors, a psychologist and representatives of the patients association). A mean score of 0 indicates maximum burden, a mean score of 10 means no burden at all.

  2. Gold Standard questionnaire score [ Time Frame: Directly after EEnG procedure, which is a one time procedure the subjects in this study will undergo, or directly after the gold standard procedure, which some subjects will undergo in the near future at time of inclusion ]
    Total burden score of Gold Standard procedure used to diagnose motility disorder as assessed by a self created questionnaire (in collaboration with medical doctors, a psychologist and representatives of the patients association). A mean score of 0 indicates maximum burden, a mean score of 10 means no burden at all.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All subjects fulfilling the in- and exclusion criteria will be included. Participants with (suspected) motility disorder will be recruited mainly in the Radboudumc and with the help from the Hirschsprung's patient association.
Criteria

Inclusion Criteria:

  • All participants:
  • Age ≤ 11 years for babies and children
  • Age ≥ 18 years for adults.

Patients

  • For babies/children:

    • suffering from surgically untreated HSCR as determined by a rectal biopsy, or
    • suspected of HSCR, for which a rectal biopsy is planned
  • For adults: Suffering from a (suspected,) surgically untreated functional colonic motility disorder (such as slow-transit constipation, idiopathic/therapy resistant constipation of the colon), as diagnosed previously or will be diagnosed in the near future using the gold standard method.

Exclusion criteria:

  • All participants:
  • For adults: BMI > 27 kg/m2
  • For babies/children: weight for length > 2.5 standard deviations of WHO Child Growth Standard
  • Pregnancy
  • Diabetes
  • Any food intolerance
  • Presence of an intestinal stoma
  • Use of continuous tube feeding
  • Healthy controls:
  • The presence of any known gastro-intestinal conditions
  • Use of laxatives in the past two years
  • Participants with (suspected) motility disorder:
  • (Part of) colon removed
  • Inflammatory bowel disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04624334


Locations
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Netherlands
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525 GA
Sponsors and Collaborators
Radboud University Medical Center
Investigators
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Principal Investigator: S.M.B.I. Botden, MD Radboud University Medical Center
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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT04624334    
Other Study ID Numbers: 110933
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be available to other researchers on reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After publication of the results.
Access Criteria: Upon reasonable request via e-mail.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hirschsprung Disease
Colonic Diseases
Constipation
Signs and Symptoms, Digestive
Digestive System Abnormalities
Digestive System Diseases
Megacolon
Intestinal Diseases
Gastrointestinal Diseases
Congenital Abnormalities