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Идёт набор NCT06900491

Irritable Bowel Syndrome Regional Cohort

— Наблюдательное Irritable Bowel Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: self-questionnaires, unique collection of saddles.
Кому может быть актуально
Состояния в реестре: Irritable Bowel Syndrome. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

Development of a Regional Irritable Bowel Syndrome Cohort

Обзор

Setting up a regional (multicentre), longitudinal cohort of people suffering from irritable bowel syndrome followed up in consultation to study the natural history of the disease and its prognosis.

Подробное описание

The strategy of this project is to develop a regional cohort of patients suffering from irritable bowel syndrome, in order to offer harmonised phenotyping, longitudinal follow-up and the study of clinical and biological factors associated with the development of the disease and its treatment.

To achieve this, the study plans to prospectively collect a complete phenotyping of patients suffering from IBS and followed up in consultation in the participating centres (questioning, questionnaires, physiological explorations and results of complementary examinations), with follow-up of the course of the disease and which will be supplemented by stool samples for analyses of the microbiota and metabolites.

The study aims to include all patients seen prospectively in the centres over a period of 3 years and to include as many stool samples as possible during follow-up visits. This should make it possible to include a total of 600 patients. This number will be sufficient to identify subgroups of patients with similar clinical or biological characteristics of reasonable size (at least 50 to 100 subjects each) and then compare their prognosis.

Вмешательства

  • Другое self-questionnaires
    Patients will fill in these self-questionnaires on a tablet or on paper, depending on the availability of tablets in the centres, before and after consulting the doctor. These questionnaires assess the severity of the disease and quality of life.
  • Другое unique collection of saddles
    Stool samples will be taken at each visit, i.e. approximately every 6 months for patients

Первичные конечные точки

  • Clinical prognostic factors for the disease (use of recreational substances) [Срок оценки: Visit V0 (inclusion)]
  • Clinical prognostic factors for the disease (clinical history) [Срок оценки: Visit V0 (inclusion)]
  • Clinical prognostic factors for the disease (use of treatment) [Срок оценки: Visit V0 (inclusion)]
  • Clinical prognostic factors for the disease (HAD score) [Срок оценки: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]
  • Evaluation of validated questionnaires (SCOFF-F questionnaire) [Срок оценки: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]
  • Evaluation of validated questionnaires (NIAS questionnaire (ARFID)) [Срок оценки: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]
  • Evaluation of validated questionnaires (Francis score) [Срок оценки: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]
  • Evaluation of validated questionnaires (GIQLI score) [Срок оценки: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]
  • Evaluation of validated questionnaires (Fear of food questionnaire) [Срок оценки: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]
  • Evaluation of validated questionnaires (EQ-5D-5L score) [Срок оценки: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]
Вторичные конечные точки (2)
  • Metabolomic analyses [Срок оценки: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]
  • analyses carried out on stool samples (metagenomic shotgun) [Срок оценки: Visit V0 (inclusion), Visits at 6 , 12, 18, 24, 30 and 36 months]

Критерии участия

Критерии включения

  • Patient
  • Normal laboratory work-up as part of routine care (CBC, CRP)
  • Over 18 years of age
  • Patient affiliated to a social security scheme
  • Person who has read and understood the information letter and does not object to taking part in the study

Критерии исключения

  • Patient suffering from an organic digestive pathology (chronic inflammatory bowel disease, microscopic colitis when endoscopy has been performed because deemed necessary, digestive cancer, coeliac disease) or major digestive surgery (excluding appendectomy and cholecystectomy).
  • Patient refusal
  • Patient does not speak or understand French
  • A pregnant woman or a woman in labour or breastfeeding
  • Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub- guardianship or curatorship

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 4 центра
  • University Hospitol of Amiens — Amiens
  • CHU de CAEN — Caen
  • University Hospital of Lille — Lille
  • University Rouen Hospital — Rouen

Идентификаторы

NCT: NCT06900491 · 2023/0143/OB · IDRCB : 2024-A02023-44

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗