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

• ClinicalTrials.gov Identifier: NCT04624334
• Recruitment Status: Terminated
• First Posted: November 10, 2020
• Last Update Posted: May 19, 2022
• Sponsor: Radboud University Medical Center
• Information provided by (Responsible Party): Radboud University Medical Center

Study Description

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

Study Design

• 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

Groups and Cohorts

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Netherlands

Radboudumc

Nijmegen, Gelderland, Netherlands, 6525 GA

Sponsors and Collaborators

Radboud University Medical Center

Investigators

• Principal Investigator: S.M.B.I. Botden, MD; Radboud University Medical Center

More Information

• Responsible Party: Radboud University Medical Center
• ClinicalTrials.gov Identifier: NCT04624334
• Other Study ID Numbers: 110933
• First Posted: November 10, 2020
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hirschsprung Disease; Colonic Diseases; Constipation; Signs and Symptoms, Digestive; Digestive System Abnormalities; Digestive System Diseases; Megacolon; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities