Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont
Rouen, 76031, France
Location status: Recruiting
Location contact
Anne-Marie Leroi, phd
CONTACT
Anne-marie Leroi, PHd
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04918329
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Rouen, 76031, France
Location status: Recruiting
Anne-Marie Leroi, phd
CONTACT
Anne-marie Leroi, PHd
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non interventional study
Other names: Non interventional study
Time frame: 10 years
Gastrointestinal intraluminal pressures (mmHg), recorded during gastrointestinal manometry.
Time frame: 10 years
Luminal dimensions (cm)
Time frame: 10 years
ethnicity (categorical measure)
Time frame: 10 years
Gastric emptying time (minutes)
Time frame: 10 years
Cross-sectional area (CSA) (mm²) measured using the EndoFLIP® system.
Time frame: 10 years
Rectal distension compliance (Ml/mmHg) measured using a rectal barostat.
Time frame: 10 years
Percentage of hydrogen (H₂) and methane (CH₄) in exhaled breath during breath testing.
Time frame: 10 years
Mucosal abnormalities (caterogical variable)
Time frame: 10 years
Drug use (categorical variable)
Time frame: 10 years
Rome questionnaire
Time frame: 10 years
Bristol Scale
Time frame: 10 years
Francis score
Time frame: 10 years
GIQLI score
Time frame: 10 years
Cleveland Clinic Score
Time frame: 10 years
FIQL score
Time frame: 10 years
HAD questionnaire
Time frame: 10 years
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 10 years
Insomnia severity index
Time frame: 10 years
Painful bladder score
Time frame: 10 years
PAGI-SYM score
Time frame: 10 years
PAGI-QOL
Time frame: 10 years
Reflux questionnaire RDQ
Time frame: 10 years
Patient health questionnaire
Time frame: 10 years
Generalized Anxiety Disorder questionnaire
Time frame: 10 years
Kess score
Time frame: 10 years
Generalized Anxiety Disorder
Time frame: 10 years
Visceral Sensitivity Index (VSI)
Time frame: 10 years
SCOFF questionnaire
Time frame: 10 years
ARFID questionnaire
Time frame: 10 years
Ford Insomnia Response to Stress Test (FIRST)
Time frame: 10 years
PROMIS 10 Score
Time frame: 10 years
IBSQOL score
Time frame: 10 years
WRQ score
Time frame: 10 years
Gastroparesis questionnaire
Time frame: 10 years
Vaizey questionnaire
Time frame: 10 years
CISS score
Time frame: 10 years
EQ-5D-5L
Time frame: 10 years
Fear of food score
Time frame: 10 years
Food avoidance score
Time frame: 10 years
FITAS score
Time frame: 10 years
PAC-QOL
Time frame: 10 years
NBD score
Time frame: 10 years
LARS score
Time frame: 10 years
age (years)
Time frame: 10 years
sex (categorical measure)
Time frame: 10 years
Treatments (categorical measure)
Contact information is provided by the study sponsor or research team.
University Hospital, Rouen
Other
Observatory of Functionnal Digestive Disorders
Acronym: OTFI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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