An observational study in Irritable Bowel Syndrome, Dyspepsia and Functional Constipation, sponsored by University Hospital, Rouen. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by University Hospital, Rouen · Observational
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.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 160 across 191 observational studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with functional digestive disorders consulting in our centre functional digestive disorders whether or not they are sequelae of an organic pathology.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Non interventional study
Also known as: Non interventional study
Functional digestive explorations
Gastrointestinal intraluminal pressures (mmHg), recorded during gastrointestinal manometry.
Time frame: 10 years
Radiological findings
Luminal dimensions (cm)
Time frame: 10 years
Clinical data of patients with functional digestive disorders
ethnicity (categorical measure)
Time frame: 10 years
Gastric emptying study
Gastric emptying time (minutes)
Time frame: 10 years
EndoFLIP system
Cross-sectional area (CSA) (mm²) measured using the EndoFLIP® system.
Time frame: 10 years
Rectal barostat
Rectal distension compliance (Ml/mmHg) measured using a rectal barostat.
Time frame: 10 years
Breath tests
Percentage of hydrogen (H₂) and methane (CH₄) in exhaled breath during breath testing.
Time frame: 10 years
Endoscopic findings
Mucosal abnormalities (caterogical variable)
Time frame: 10 years
Drug use
Drug use (categorical variable)
Time frame: 10 years
Gastrointestinal symptoms
Rome questionnaire
Time frame: 10 years
Gastrointestinal symptoms
Bristol Scale
Time frame: 10 years
Gastrointestinal symptoms
Francis score
Time frame: 10 years
Gastrointestinal symptoms
GIQLI score
Time frame: 10 years
Gastrointestinal symptoms
Cleveland Clinic Score
Time frame: 10 years
Gastrointestinal symptoms
FIQL score
Time frame: 10 years
Symptoms of anxiety and depression
HAD questionnaire
Time frame: 10 years
Sleep assessment
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 10 years
Sleep assessment
Insomnia severity index
Time frame: 10 years
painful bladder symptom
Painful bladder score
Time frame: 10 years
Gastrointestinal symptoms
PAGI-SYM score
Time frame: 10 years
Gastrointestinal symptoms
PAGI-QOL
Time frame: 10 years
Gastrointestinal symptoms
Reflux questionnaire RDQ
Time frame: 10 years
Anxiety and depression syndrome
Patient health questionnaire
Time frame: 10 years
Anxiety symptoms
Generalized Anxiety Disorder questionnaire
Time frame: 10 years
Gastrointestinal symptoms
Kess score
Time frame: 10 years
Anxiety symptoms
Generalized Anxiety Disorder
Time frame: 10 years
Gastrointestinal symptoms
Visceral Sensitivity Index (VSI)
Time frame: 10 years
Eating behavior assessment
SCOFF questionnaire
Time frame: 10 years
Eating behavior assessment
ARFID questionnaire
Time frame: 10 years
Sleep assessment
Ford Insomnia Response to Stress Test (FIRST)
Time frame: 10 years
Global health assessment
PROMIS 10 Score
Time frame: 10 years
Gastrointestinal symptoms
IBSQOL score
Time frame: 10 years
General Health Questionnaire
WRQ score
Time frame: 10 years
Gastrointestinal symptoms
Gastroparesis questionnaire
Time frame: 10 years
Gastrointestinal symptoms
Vaizey questionnaire
Time frame: 10 years
Gastrointestinal symptoms
CISS score
Time frame: 10 years
Health assessment
EQ-5D-5L
Time frame: 10 years
Eating behavior assessment
Fear of food score
Time frame: 10 years
Eating behavior assessment
Food avoidance score
Time frame: 10 years
Eating behavior assessment
FITAS score
Time frame: 10 years
Gastrointestinal symptoms
PAC-QOL
Time frame: 10 years
Gastrointestinal symptoms
NBD score
Time frame: 10 years
Gastrointestinal symptoms
LARS score
Time frame: 10 years
Demographic data
age (years)
Time frame: 10 years
Demographic data
sex (categorical measure)
Time frame: 10 years
Gastrointestinal treatments
Treatments (categorical measure)
Time frame: 10 years
Plan to share: No — No sharing plan
Started Oct 2020 (actual). Primary completion is estimated for Oct 2030, 120 months after the start.
Of 51 non-industry observational studies under Irritable Bowel Syndrome, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 193. This study's planned 120 months is above that.
Counting every sponsor, half of 65 studies reached it within 40 months; a quarter within 21 and three quarters within 109.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.