Идёт набор NCT06502873

Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease

Без фазы С лечением Inflammatory Bowel Disease (IBD)

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: biological samples collection.
Кому может быть актуально: Состояния в реестре: Inflammatory Bowel Disease (IBD). 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: Бельгия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease in the Context of the Translational Study of Biomarkers of Intestinal Dysbiosis (ELITE Walloon Project)

Обзор

The objective of this study is to constitute cohorts of IBD versus non-IBD patients to identify (a) new biomarker(s) of intestinal dysbiosis associated with inflammatory bowel disease, and develop a prototype for assaying such marker(s) in blood.

Вмешательства

Процедура biological samples collection
Collection of biological samples from the same cohorts: faeces, serum, intestinal biopsies

Первичные конечные точки

Number of patients recruited in each cohort [Срок оценки: 27 months]
number of faeces samples collected in each cohort [Срок оценки: 27 months]
Number of plasma samples collected in each cohort [Срок оценки: 27 months]
Number of biopsy samples collected in each cohort [Срок оценки: 27 months]

Критерии участия

Критерии включения

General criteria:

Male or female ≥ 18 years old
Able to follow the instructions of the study
Having signed an informed consent

Specific for Crohn cohort:

A confirmed diagnosis of IBD
Rectal or colonic or ileocolic involvement
Patients with CD presenting inflammatory flare and disease extent in the colon or ileocolic region with:
A clinical activity defined by an average of four or more instances of very soft or liquid stools daily or an abdominal pain score of 2 or more OR a CDAI (CD Activity Index) ≥ 220 OR a Harvey-Bradshaw Index > 8 OR a faecal calprotectin ≥ 250 µg/g And
A endoscopic activity defined by a SES-CD (Simple Endoscopic Score for Crohn Disease) ≥ 6 or a CDEIS (CD Endoscopic Index score) ≥ 7
Patients with UC presenting inflammatory flare with:

A clinical activity defined by a modified Mayo score ≥ 3 OR a Simple Clinical Colitis Activity Index ≥5 OR Patient Reported Outcome (PRO2) ≥ 4 with a subscore of rectal bleeding ≥1 OR a faecal calprotectin ≥ 250 µg/g AND An endoscopic activity defined by a Mayo endoscopic sub-score ≥ 2

Specific for Control cohort:

Patient with no colonic lesion(s) visible during the endoscopical examination (neither Crohn's nor other colitis nor cancer)

Критерии исключения

General criteria:

Commercial Pharmaceutical probiotic administration within the previous month
Treatment with antibiotics (whatever the route of administration) within last 3 months
Non-remission Cancer or in remission for less than 6 months
Any contraindication to colonoscopy and/or biopsy, left to PI discretion
Under guardianship or judiciable protection
Pregnant or breastfeeding women
Currently participating or having participated in the last 3 months to a clinical study with investigational medicine or food supplement

Specific for Crohn cohort: