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| ID | Type | Description | Link |
|---|---|---|---|
| 2019/120/OB | Registry Identifier | Functional Digestive Disorders Observatory |
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Functional digestive pathologies are defined by symptoms such as functional dyspepsia, gastroesophageal reflux, irritable bowel syndrome, gastroesophageal reflux, functional constipation, functional diarrhea, functional bloating, the opioid-induced constipation and fecal incontinence, without organic substratum. These diseases are very common in the general population (20%) and represent the first cause of consultation in city gastroenterology. The pathophysiology of these functional disorders is complex and often multifactorial: disturbances in digestive motility, altered visceral sensitivity, sphincter dysfunction, post-surgery, intestinal inflammation, dysbiosis, and impairment of the gut-brain axis. For example, it has been shown that one in four patients with inflammatory bowel disease in confirmed remission report digestive symptoms consistent with a functional bowel disorder, suggesting a possible pathophysiological continuum between these two conditions.
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.
Functional digestive pathologies are defined by symptoms such as functional dyspepsia, gastroesophageal reflux, irritable bowel syndrome, gastroesophageal reflux, functional constipation, functional diarrhea, functional bloating, the opioid-induced constipation and fecal incontinence, without organic substratum. These diseases are very common in the general population (20%) and represent the first cause of consultation in city gastroenterology.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study | Other | Non interventional study |
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| Measure | Description | Time Frame |
|---|---|---|
| Functional digestive explorations | Gastrointestinal intraluminal pressures (mmHg), recorded during gastrointestinal manometry. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological findings | Luminal dimensions (cm) | 10 years |
| Clinical data of patients with functional digestive disorders | ethnicity (categorical measure) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with functional digestive disorders consulting in our centre functional digestive disorders whether or not they are sequelae of an organic pathology.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne-Marie AL LEROI, Professor | Contact | 33232888990 | 65461 | anne-marie.leroi@chu-rouen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont | Recruiting | Rouen | 76031 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37874655 | Derived | 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. | |
| 35187671 | Derived |
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No sharing plan
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D004415 | Dyspepsia |
| D004688 | Encopresis |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Blood, fecaes, biopsies, urine,
| 10 years |
| Gastric emptying study | Gastric emptying time (minutes) | 10 years |
| EndoFLIP system | Cross-sectional area (CSA) (mm²) measured using the EndoFLIP® system. | 10 years |
| Rectal barostat | Rectal distension compliance (Ml/mmHg) measured using a rectal barostat. | 10 years |
| Breath tests | Percentage of hydrogen (H₂) and methane (CH₄) in exhaled breath during breath testing. | 10 years |
| Endoscopic findings | Mucosal abnormalities (caterogical variable) | 10 years |
| Drug use | Drug use (categorical variable) | 10 years |
| Gastrointestinal symptoms | Rome questionnaire | 10 years |
| Gastrointestinal symptoms | Bristol Scale | 10 years |
| Gastrointestinal symptoms | Francis score | 10 years |
| Gastrointestinal symptoms | GIQLI score | 10 years |
| Gastrointestinal symptoms | Cleveland Clinic Score | 10 years |
| Gastrointestinal symptoms | FIQL score | 10 years |
| Symptoms of anxiety and depression | HAD questionnaire | 10 years |
| Sleep assessment | Pittsburgh Sleep Quality Index (PSQI) | 10 years |
| Sleep assessment | Insomnia severity index | 10 years |
| painful bladder symptom | Painful bladder score | 10 years |
| Gastrointestinal symptoms | PAGI-SYM score | 10 years |
| Gastrointestinal symptoms | PAGI-QOL | 10 years |
| Gastrointestinal symptoms | Reflux questionnaire RDQ | 10 years |
| Anxiety and depression syndrome | Patient health questionnaire | 10 years |
| Anxiety symptoms | Generalized Anxiety Disorder questionnaire | 10 years |
| Gastrointestinal symptoms | Kess score | 10 years |
| Anxiety symptoms | Generalized Anxiety Disorder | 10 years |
| Gastrointestinal symptoms | Visceral Sensitivity Index (VSI) | 10 years |
| Eating behavior assessment | SCOFF questionnaire | 10 years |
| Eating behavior assessment | ARFID questionnaire | 10 years |
| Sleep assessment | Ford Insomnia Response to Stress Test (FIRST) | 10 years |
| Global health assessment | PROMIS 10 Score | 10 years |
| Gastrointestinal symptoms | IBSQOL score | 10 years |
| General Health Questionnaire | WRQ score | 10 years |
| Gastrointestinal symptoms | Gastroparesis questionnaire | 10 years |
| Gastrointestinal symptoms | Vaizey questionnaire | 10 years |
| Gastrointestinal symptoms | CISS score | 10 years |
| Health assessment | EQ-5D-5L | 10 years |
| Eating behavior assessment | Fear of food score | 10 years |
| Eating behavior assessment | Food avoidance score | 10 years |
| Eating behavior assessment | FITAS score | 10 years |
| Gastrointestinal symptoms | PAC-QOL | 10 years |
| Gastrointestinal symptoms | NBD score | 10 years |
| Gastrointestinal symptoms | LARS score | 10 years |
| Demographic data | age (years) | 10 years |
| Demographic data | sex (categorical measure) | 10 years |
| Gastrointestinal treatments | Treatments (categorical measure) | 10 years |
| 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. |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |