Colon Diseasenon-CoMotiNCT04624334
Non-invasive Assessment of Colonic Motility
An observational study of Colon Disease and Functional Constipation, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colon Disease, Functional Constipation, Electroenterography
- What is being tested?
- Elektro-Entero-Graphy procedure, EEnG Questionnaire and Gold Standard Questionnaire
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Feb 2021to 12 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electro-Entero-Graphy (EEnG) for Non-invasive Diagnosis of Motility Disorders of the Bowel
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.
- Conditions
- Colon Disease, Functional Constipation, Electroenterography, Slow Transit, Hirschsprung Disease
- Being tested
- Elektro-Entero-Graphy procedure, EEnG Questionnaire, Gold Standard Questionnaire
- Medical subject headings
- Colonic Diseases, Hirschsprung Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elektro-Entero-Graphy procedureOther
Fasting, after which pre- and postprandial EEnG measurements are performed.
EEnG QuestionnaireOther
Filling out questionnaire about EEnG procedure.
Gold Standard QuestionnaireOther
Filling out questionnaire about Gold Standard diagnostic used to diagnose colonic motility disorder.
| Study group | Role | What they receive |
|---|---|---|
| Children with motility disorder | Not described Receives: Other: Elektro-Entero-Graphy procedure; Other: EEnG Questionnaire; Other: Gold Standard Questionnaire | |
| Healthy children | Not described Receives: Other: Elektro-Entero-Graphy procedure; Other: EEnG Questionnaire | |
| Adults with motility disorder | Not described Receives: Other: Elektro-Entero-Graphy procedure; Other: EEnG Questionnaire; Other: Gold Standard Questionnaire | |
| Healthy adults | Not described Receives: Other: Elektro-Entero-Graphy procedure; Other: EEnG Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power Percent Difference
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).
Measured: During EEnG procedure
Secondary outcomes (2)
EEnG questionnaire score
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.
Measured: Directly after EEnG procedure, which is a one time procedure the subjects in this study will undergo
Gold Standard questionnaire score
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start25 Feb 2021
- Primary completion12 May 2022
- Study completion12 May 2022
Why it stopped: Money issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- S.M.B.I. Botden, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624334
- Sponsor's protocol ID
- 110933
- Acronym
- non-CoMoti
- Status last verified
- Apr 2022
- First submitted
- 29 Oct 2020
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available to other researchers on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electro-Entero-Graphy (EEnG) for Non-invasive Diagnosis of Motility Disorders of the Bowel
- ClinicalTrials.gov ID
- NCT04624334
- Acronym / sponsor ID
- non-CoMoti / 110933
- Conditions
- Colon Disease, Functional Constipation, Electroenterography, Slow Transit, Hirschsprung Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Money issues
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children with motility disorder | – | Other: Elektro-Entero-Graphy procedure, Other: EEnG Questionnaire, Other: Gold Standard Questionnaire |
| Healthy children | – | Other: Elektro-Entero-Graphy procedure, Other: EEnG Questionnaire |
| Adults with motility disorder | – | Other: Elektro-Entero-Graphy procedure, Other: EEnG Questionnaire, Other: Gold Standard Questionnaire |
| Healthy adults | – | Other: Elektro-Entero-Graphy procedure, Other: EEnG Questionnaire |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- All participants:
- Age ≤ 11 years for babies and children
- Age ≥ 18 years for adults.
- Patients
- For babies/children:
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elektro-Entero-Graphy procedureFasting, after which pre- and postprandial EEnG measurements are performed. | Other | Adults with motility disorder, Children with motility disorder, Healthy adults, Healthy children |
| EEnG QuestionnaireFilling out questionnaire about EEnG procedure. | Other | Adults with motility disorder, Children with motility disorder, Healthy adults, Healthy children |
| Gold Standard QuestionnaireFilling out questionnaire about Gold Standard diagnostic used to diagnose colonic motility disorder. | Other | Adults with motility disorder, Children with motility disorder |
Primary outcome
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).
2 secondary outcomes
EEnG questionnaire score
Time frame: Directly after EEnG procedure, which is a one time procedure the subjects in this study will undergo
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
Results and safety
The study was stopped early (reason given: Money issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: Yes. IPD will be available to other researchers on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S.M.B.I. Botden, MD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Disease and Functional Constipation, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Money issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power Percent Difference (time frame: During EEnG procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.