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NCT Number: NCT04918329

Functional Digestive Disorders Observatory

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont

Rouen, 76031, France

Location status: Recruiting

Location contact

Anne-Marie Leroi, phd

CONTACT

[email protected]

00-33-2-32-88-80-39

Anne-marie Leroi, PHd

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.)

Treatment and study plan

observational study

Other

Non interventional study

Other names: Non interventional study

Primary outcomes

  1. Functional digestive explorations

    Time frame: 10 years

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

Secondary outcomes

  1. Radiological findings

    Time frame: 10 years

    Luminal dimensions (cm)

  2. Clinical data of patients with functional digestive disorders

    Time frame: 10 years

    ethnicity (categorical measure)

  3. Gastric emptying study

    Time frame: 10 years

    Gastric emptying time (minutes)

  4. EndoFLIP system

    Time frame: 10 years

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

  5. Rectal barostat

    Time frame: 10 years

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

  6. Breath tests

    Time frame: 10 years

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

  7. Endoscopic findings

    Time frame: 10 years

    Mucosal abnormalities (caterogical variable)

  8. Drug use

    Time frame: 10 years

    Drug use (categorical variable)

  9. Gastrointestinal symptoms

    Time frame: 10 years

    Rome questionnaire

  10. Gastrointestinal symptoms

    Time frame: 10 years

    Bristol Scale

  11. Gastrointestinal symptoms

    Time frame: 10 years

    Francis score

  12. Gastrointestinal symptoms

    Time frame: 10 years

    GIQLI score

  13. Gastrointestinal symptoms

    Time frame: 10 years

    Cleveland Clinic Score

  14. Gastrointestinal symptoms

    Time frame: 10 years

    FIQL score

  15. Symptoms of anxiety and depression

    Time frame: 10 years

    HAD questionnaire

  16. Sleep assessment

    Time frame: 10 years

    Pittsburgh Sleep Quality Index (PSQI)

  17. Sleep assessment

    Time frame: 10 years

    Insomnia severity index

  18. painful bladder symptom

    Time frame: 10 years

    Painful bladder score

  19. Gastrointestinal symptoms

    Time frame: 10 years

    PAGI-SYM score

  20. Gastrointestinal symptoms

    Time frame: 10 years

    PAGI-QOL

  21. Gastrointestinal symptoms

    Time frame: 10 years

    Reflux questionnaire RDQ

  22. Anxiety and depression syndrome

    Time frame: 10 years

    Patient health questionnaire

  23. Anxiety symptoms

    Time frame: 10 years

    Generalized Anxiety Disorder questionnaire

  24. Gastrointestinal symptoms

    Time frame: 10 years

    Kess score

  25. Anxiety symptoms

    Time frame: 10 years

    Generalized Anxiety Disorder

  26. Gastrointestinal symptoms

    Time frame: 10 years

    Visceral Sensitivity Index (VSI)

  27. Eating behavior assessment

    Time frame: 10 years

    SCOFF questionnaire

  28. Eating behavior assessment

    Time frame: 10 years

    ARFID questionnaire

  29. Sleep assessment

    Time frame: 10 years

    Ford Insomnia Response to Stress Test (FIRST)

  30. Global health assessment

    Time frame: 10 years

    PROMIS 10 Score

  31. Gastrointestinal symptoms

    Time frame: 10 years

    IBSQOL score

  32. General Health Questionnaire

    Time frame: 10 years

    WRQ score

  33. Gastrointestinal symptoms

    Time frame: 10 years

    Gastroparesis questionnaire

  34. Gastrointestinal symptoms

    Time frame: 10 years

    Vaizey questionnaire

  35. Gastrointestinal symptoms

    Time frame: 10 years

    CISS score

  36. Health assessment

    Time frame: 10 years

    EQ-5D-5L

  37. Eating behavior assessment

    Time frame: 10 years

    Fear of food score

  38. Eating behavior assessment

    Time frame: 10 years

    Food avoidance score

  39. Eating behavior assessment

    Time frame: 10 years

    FITAS score

  40. Gastrointestinal symptoms

    Time frame: 10 years

    PAC-QOL

  41. Gastrointestinal symptoms

    Time frame: 10 years

    NBD score

  42. Gastrointestinal symptoms

    Time frame: 10 years

    LARS score

  43. Demographic data

    Time frame: 10 years

    age (years)

  44. Demographic data

    Time frame: 10 years

    sex (categorical measure)

  45. Gastrointestinal treatments

    Time frame: 10 years

    Treatments (categorical measure)

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Marie AL LEROI, Professor

CONTACT

[email protected]

33232888990 ext. 65461

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Observatory of Functionnal Digestive Disorders

Acronym: OTFI

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Jun 8, 2021
Registry last updated
Jan 8, 2026

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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