Gastrointestinal Motility DisorderNCT04764019
Intestinal Dysmotility in Patients With Functional Digestive Symptoms
A study testing High resolution intestinal manometry in people with Gastrointestinal Motility Disorder, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Automatic and non-invasive diagnostic methods based on the analysis of internal (intraluminal) and external (abdominal) images have been recently developed to measure intestinal motility. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Motility Disorder
- What is being tested?
- High resolution intestinal manometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 7 Nov 2018to 28 Feb 2022
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients: digestive symptoms
- Healthy subjects: asymptomatic
Who cannot join
- Patients: organic disorders
- Healthy subjects: organic disorders
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Vall d'Hebron
Barcelona, 08035
Carolina Malagelada, MD, 34 932746259, cmalagelada@vhebron.net
About this study
Automatic and non-invasive diagnostic methods based on the analysis of internal (intraluminal) and external (abdominal) images have been recently developed to measure intestinal motility. In patients with severe motor disorders, such as intestinal pseudo-obstruction, these new non-invasive techniques have shown to be equivalent to conventional intestinal manometry, the current gold-standard. However, these new techniques also detect less obvious signs of intestinal motor dysfunction, which are not detectable by conventional manometry.
High resolution manometry has been recently been applied to other parts of the digestive tract with great success, and probably will replace the actual gold-standard for intestinal motility evaluation. The investigators expect high-resolution manometry to be more sensitive than conventional manometry to the subtle motility disturbances detected by the new non-invasive techniques.
The purpose of this project is to demonstrate that intestinal motor function can be measured more sensitively and accurately using a combination of new technologies: high resolution manometry and the non-invasive diagnostic methods based on the analysis of images. The combined use of these techniques, following a step-wise algorithm, could allow to determine the mechanism, the affected regions and severity of the dysfunction in patients with intestinal dysmotility.
- Conditions
- Gastrointestinal Motility Disorder
- Being tested
- High resolution intestinal manometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resolution intestinal manometryDiagnostic test
Evaluation of intestinal manometry by the use a high resolution intestinal manometry catheter with 34 closely spaced sensors.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients with chronic digestive symptoms in whom intestinal dysmotility is suspected Receives: Diagnostic Test: High resolution intestinal manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contractile activity
Number of contractions
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start7 Nov 2018
- Primary completion15 Jul 2021
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Motility DisorderStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764019
- Sponsor's protocol ID
- PR(AG)56/2018
- Status last verified
- Mar 2021
- First submitted
- 17 Feb 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Malagelada C, Karunaratne TB, Accarino A, Cogliandro RF, Landolfi S, Gori A, Boschetti E, Malagelada JR, Stanghellini V, Azpiroz F, De Giorgio R. Comparison between small bowel manometric patterns and full-thickness biopsy histopathology in severe intestinal dysmotility. Neurogastroenterol Motil. 2018 Mar;30(3). doi: 10.1111/nmo.13219. Epub 2017 Sep 22.
PubMed 28941004Alcala-Gonzalez LG, Nieto A, Accarino A, Azpiroz F, Malagelada C. High-resolution versus conventional manometry for the diagnosis of small bowel motor dysfunction. Neurogastroenterol Motil. 2024 Nov;36(11):e14907. doi: 10.1111/nmo.14907. Epub 2024 Sep 2.
PubMed 39223844
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Dysmotility in Patients With Functional Digestive Symptoms
- ClinicalTrials.gov ID
- NCT04764019
- Acronym / sponsor ID
- PR(AG)56/2018
- Conditions
- Gastrointestinal Motility Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 21 Feb 2021 (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.
Automatic and non-invasive diagnostic methods based on the analysis of internal (intraluminal) and external (abdominal) images have been recently developed to measure intestinal motility. In patients with severe motor disorders, such as intestinal pseudo-obstruction, these new non-invasive techniques have shown to be equivalent to conventional intestinal manometry, the current gold-standard. However, these new techniques also detect less obvious signs of intestinal motor dysfunction, which are not detectable by conventional manometry.
High resolution manometry has been recently been applied to other parts of the digestive tract with great success, and probably will replace the actual gold-standard for intestinal motility evaluation. The investigators expect high-resolution manometry to be more sensitive than conventional manometry to the subtle motility disturbances detected by the new non-invasive techniques.
The purpose of this project is to demonstrate that intestinal motor function can be measured more sensitively and accurately using a combination of new technologies: high resolution manometry and the non-invasive diagnostic methods based on the analysis of images. The combined use of these techniques, following a step-wise algorithm, could allow to determine the mechanism, the affected regions and severity of the dysfunction in patients with intestinal dysmotility.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Diagnostic Test: High resolution intestinal manometryPatients with chronic digestive symptoms in whom intestinal dysmotility is suspected |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients: digestive symptoms
- Healthy subjects: asymptomatic
Key exclusion criteria (2 listed)
- Patients: organic disorders
- Healthy subjects: organic disorders
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 |
|---|---|---|
| High resolution intestinal manometryEvaluation of intestinal manometry by the use a high resolution intestinal manometry catheter with 34 closely spaced sensors. | Diagnostic test | Patients |
Primary outcome
Contractile activity
Time frame: 10 minutes
Number of contractions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Background: PubMed 28941004Malagelada C, Karunaratne TB, Accarino A, Cogliandro RF, Landolfi S, Gori A, Boschetti E, Malagelada JR, Stanghellini V, Azpiroz F, De Giorgio R. Comparison between small bowel manometric patterns and full-thickness biopsy histopathology in severe intestinal dysmotility. Neurogastroenterol Motil. 2018 Mar;30(3). doi: 10.1111/nmo.13219. Epub 2017 Sep 22.
- Derived from this study: PubMed 39223844Alcala-Gonzalez LG, Nieto A, Accarino A, Azpiroz F, Malagelada C. High-resolution versus conventional manometry for the diagnosis of small bowel motor dysfunction. Neurogastroenterol Motil. 2024 Nov;36(11):e14907. doi: 10.1111/nmo.14907. Epub 2024 Sep 2.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High resolution intestinal manometry in people with Gastrointestinal Motility Disorder, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Nov 2021. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolina Malagelada, MD (34 932746259, cmalagelada@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contractile activity (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04764019, which also lists 2 linked publications.
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 22 Nov 2021.