Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Dr. Arnaud Bourreille
For each patient, the study will be conducted in accordance with the following schedule:
Information/inclusion visit: D-30 (± 30 days)
* Full information about the trial
* Verification of inclusion and non-inclusion criteria
* Acquisition of informed consent (either the same day or after a period of reflexion)
* Medical and surgical history
* Clinical examination
Endoscopic visit: D0 On two consecutive days or within a maximum of seven days but obligatorily before the anti-Tumor Necrosis Factor (TNF) alpha treatment
* Faecal sample (calprotectin)
* Clinical examination
* Endoscopic examination by PillCamCOLON (C2) then by conventional endoscopy (colonoscopy)
-The endoscopic examinations will each be analyzed by a different endoscopist working in a blinded evaluation. An UC activity score will be calculated depending on two scores: MAYO and UCEIS.
* Notification of Adverse Event (AE) / Serious Adverse Event (SAE)
Follow-up visit: W12 (12 weeks ± 5 days after D0)
* Faecal sample (calprotectin)
* Clinical examination
* Endoscopic examination by PillCamCOLON (C2) then by conventional endoscopy (coloscopy)
-The endoscopic examinations will each be analyzed by a different endoscopist working in a blinded evaluation. An UC activity score will be evaluated depending on two scores: MAYO and UCEIS.
* Notification of AE/SAE
End-of-study visit (possibly by telephone) W14 (± 5 days)
\*Notification of AE/SAE
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patient between 18 and 70 years old
Patient with UC requiring treatment with anti-TNFalpha or vedolizumab
Patient affiliated to a social security scheme
Patient able to understand and follow the study instructions
Patient having signed an informed consent form
You may not be if
Patient with severe and acute colitis
Patient with Crohn's disease or non-classified colitis
Patient with an indication for surgical management of UC
Patient with a history of sub-total or total colectomy, or with colostomy or ileostomy.
Patient with a history of intestinal irradiation
Patient with a known or suspected intestinal stricture
Patient with clinical signs suggestive of intestinal stricture
Patient with dysphagia with choking on solid food or swallowing disorders
Patient with a contra-indication for an anti TNFalpha treatment
Patient with a contra-indication for conventional endoscopy (colonoscopy or recto-sigmoidoscopy)
Patient with congestive heart failure or severe renal impairment
Patient with a pacemaker or other implanted electronic medical device
Patient participating in another interventional clinical trial
Pregnant or nursing woman
Vulnerable individuals: persons deprived of liberty, under tutelage or guardianship
