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Irritable Bowel SyndromeOTFINCT04918329

Functional Digestive Disorders Observatory

An observational study of Irritable Bowel Syndrome and Dyspepsia, run by University Hospital, Rouen at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Observational study
How many people
2,000 participants
Where
1 siteFrance
Study dates
9 Oct 2020to 9 Oct 2030
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with functional digestive disorders consulting in our centre functional digestive disorders whether or not they are sequelae of an organic pathology.

Who may be able to join

  • Patients over 18 years of age;
  • 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

Who cannot join

  • Person deprived of liberty by administrative or judicial decision or major protected subject (under guardianship or curatorship);
  • Patients unable for any reason to read, understand, respond questionnaires (visual, psychiatric, cognitive, etc.)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anne-Marie AL LEROI, Professor contact

33232888990 ext. 65461

anne-marie.leroi@chu-rouen.fr

France1 site, 1 recruiting

  • Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont

    Rouen, 76031

    Anne-Marie Leroi, phd, 00-33-2-32-88-80-39, anne-marie.leroi@chu-rouen.fr

    Anne-marie Leroi, PHd

    Recruiting

Other trials in France

About this study

Official title: Observatory of Functionnal Digestive Disorders

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.

Read the detailed description

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.

Being tested
Observational study
Keywords
Observatory, functional digestive disorders
Medical subject headings
Irritable Bowel Syndrome, Dyspepsia, Encopresis, Abdominal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational studyOther

    Also called Non interventional study

    Non interventional study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional digestive explorations

    Gastrointestinal intraluminal pressures (mmHg), recorded during gastrointestinal manometry.

    Measured: 10 years

Secondary outcomes (45)

  1. Radiological findings

    Luminal dimensions (cm)

    Measured: 10 years

  2. Clinical data of patients with functional digestive disorders

    ethnicity (categorical measure)

    Measured: 10 years

  3. Gastric emptying study

    Gastric emptying time (minutes)

    Measured: 10 years

  4. EndoFLIP system

    Cross-sectional area (CSA) (mm²) measured using the EndoFLIP® system.

    Measured: 10 years

  5. Rectal barostat

    Rectal distension compliance (Ml/mmHg) measured using a rectal barostat.

    Measured: 10 years

  6. Breath tests

    Percentage of hydrogen (H₂) and methane (CH₄) in exhaled breath during breath testing.

    Measured: 10 years

  7. Endoscopic findings

    Mucosal abnormalities (caterogical variable)

    Measured: 10 years

  8. Drug use

    Drug use (categorical variable)

    Measured: 10 years

  9. Gastrointestinal symptoms

    Rome questionnaire

    Measured: 10 years

  10. Gastrointestinal symptoms

    Bristol Scale

    Measured: 10 years

  11. Gastrointestinal symptoms

    Francis score

    Measured: 10 years

  12. Gastrointestinal symptoms

    GIQLI score

    Measured: 10 years

  13. Gastrointestinal symptoms

    Cleveland Clinic Score

    Measured: 10 years

  14. Gastrointestinal symptoms

    FIQL score

    Measured: 10 years

  15. Symptoms of anxiety and depression

    HAD questionnaire

    Measured: 10 years

  16. Sleep assessment

    Pittsburgh Sleep Quality Index (PSQI)

    Measured: 10 years

  17. Sleep assessment

    Insomnia severity index

    Measured: 10 years

  18. painful bladder symptom

    Painful bladder score

    Measured: 10 years

  19. Gastrointestinal symptoms

    PAGI-SYM score

    Measured: 10 years

  20. Gastrointestinal symptoms

    PAGI-QOL

    Measured: 10 years

  21. Gastrointestinal symptoms

    Reflux questionnaire RDQ

    Measured: 10 years

  22. Anxiety and depression syndrome

    Patient health questionnaire

    Measured: 10 years

  23. Anxiety symptoms

    Generalized Anxiety Disorder questionnaire

    Measured: 10 years

  24. Gastrointestinal symptoms

    Kess score

    Measured: 10 years

  25. Anxiety symptoms

    Generalized Anxiety Disorder

    Measured: 10 years

  26. Gastrointestinal symptoms

    Visceral Sensitivity Index (VSI)

    Measured: 10 years

  27. Eating behavior assessment

    SCOFF questionnaire

    Measured: 10 years

  28. Eating behavior assessment

    ARFID questionnaire

    Measured: 10 years

  29. Sleep assessment

    Ford Insomnia Response to Stress Test (FIRST)

    Measured: 10 years

  30. Global health assessment

    PROMIS 10 Score

    Measured: 10 years

  31. Gastrointestinal symptoms

    IBSQOL score

    Measured: 10 years

  32. General Health Questionnaire

    WRQ score

    Measured: 10 years

  33. Gastrointestinal symptoms

    Gastroparesis questionnaire

    Measured: 10 years

  34. Gastrointestinal symptoms

    Vaizey questionnaire

    Measured: 10 years

  35. Gastrointestinal symptoms

    CISS score

    Measured: 10 years

  36. Health assessment

    EQ-5D-5L

    Measured: 10 years

  37. Eating behavior assessment

    Fear of food score

    Measured: 10 years

  38. Eating behavior assessment

    Food avoidance score

    Measured: 10 years

  39. Eating behavior assessment

    FITAS score

    Measured: 10 years

  40. Gastrointestinal symptoms

    PAC-QOL

    Measured: 10 years

  41. Gastrointestinal symptoms

    NBD score

    Measured: 10 years

  42. Gastrointestinal symptoms

    LARS score

    Measured: 10 years

  43. Demographic data

    age (years)

    Measured: 10 years

  44. Demographic data

    sex (categorical measure)

    Measured: 10 years

  45. Gastrointestinal treatments

    Treatments (categorical measure)

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2021
  2. Study start9 Oct 2020
  3. Primary completion9 Oct 2030 (estimated)
  4. Study completion9 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04918329
Sponsor's protocol ID
2019/120/OB
Other IDs
2019/120/OB
Acronym
OTFI
Status last verified
Dec 2025
First submitted
27 May 2021
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No sharing plan

Publications

  • 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.

    PubMed 37874655

  • 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.

    PubMed 35187671

Questions about this trial

What is this clinical trial studying?

An observational study of Irritable Bowel Syndrome and Dyspepsia, run by University Hospital, Rouen at 1 site in France.

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 5 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: looking for participants now, as of the sponsor's last update on 8 Jan 2026. 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 France. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anne-Marie AL LEROI, Professor (33232888990 ext. 65461, anne-marie.leroi@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional digestive explorations (time frame: 10 years). 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 NCT04918329, 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 8 Jan 2026.

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