Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2020-10-09
2030-10-09
Brief Summary
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The objective of this study is to collect prospective clinical and tests data and a biological collection from biological samples (digestive biopsies, blood, urine and fecal samples) collected as part of the standard care. This collection could identify diagnostic or prognostic markers of the therapeutic response.
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Detailed Description
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The pathophysiology of these functional disorders is complex and often multifactorial: digestive motility disorders, digestive sensitivity disorders, sphincter dysfunction, post-surgery, intestinal inflammation, dysbiosis, disruption of the gut-brain axis. For example, it has been shown that one in four patients with proven remission of chronic inflammatory bowel disease reports digestive symptoms compatible with a functional intestinal disorder, suggesting a pathophysiological continuum between these two conditions.
In our center, patients with functional digestive disorders undergo a comprehensive assessment that evolves in line with scientific advances and the emergence of new diagnostic or prognostic tools. This assessment helps to identify the pathophysiological mechanisms involved in the functional digestive disorder: disturbances in digestive motility, visceral hypersensitivity, mucosal alterations, sub-inflammatory syndrome, and dysfunction of the gut-brain axis. All of these abnormalities may be promoted by a genetic predisposition leading to alterations in neurotransmitters, immune function, mucosal integrity, and so on.
Our objective is to study the pathophysiological mechanisms, including genetic factors, responsible for functional digestive disorders as a whole, whether or not they are sequelae of an organic pathology.
To do that, we collect prospective clinical and tests data and we perform a biological collection from biological samples (digestive biopsies, blood, urine and fecal samples) collected as part of the standard care. This collection could identify diagnostic or prognostic markers of the therapeutic response. The investigators hope that a better knowledge of the pathophysiology of digestive functional diseases will improve the therapeutic management by making a therapeutic choice based on the observed pathophysiological abnormalities.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Observational study
Non interventional study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with functional digestive disorder for more of 3 months;
* Patients assessed as part of routine care;
* Patients affiliated to the Social Security ;
* Patients not opposed to participation in the Centre
Exclusion Criteria
* Patients unable for any reason to read, understand, respond questionnaires (visual, psychiatric, cognitive, etc.)
18 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Anne Marie LEROI
Principal Investigator
Locations
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Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Soliman H, Wuestenberghs F, Desprez C, Leroi AM, Melchior C, Gourcerol G. Physiological characterization of gastric emptying using high-resolution antropyloroduodenal manometry. Am J Physiol Gastrointest Liver Physiol. 2024 Jan 1;326(1):G16-G24. doi: 10.1152/ajpgi.00101.2023. Epub 2023 Oct 24.
Gourcerol G, Melchior C, Wuestenberghs F, Desprez C, Prevost G, Grosjean J, Leroi AM, Tavolacci MP. Delayed gastric emptying as an independent predictor of mortality in gastroparesis. Aliment Pharmacol Ther. 2022 Apr;55(7):867-875. doi: 10.1111/apt.16827. Epub 2022 Feb 20.
Other Identifiers
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2019/120/OB
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019/120/OB
Identifier Type: -
Identifier Source: org_study_id
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