Measurement of Oxidation Reduction Potential in the Colon Using an Ingestible Sensor in Patietns With Ulcerative Colitis (UC) and Colorectal Cancer (CRC)

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral, Diagnostic test
Study Type: Observational
SUMMARY

The goal of this observational pilot study with invasive measurements is to explore whether an ingestible sensor pill can be of use in diagnosis or monitoring of disease in patients with ulcerative colitis or colorectal cancer. The main questions it aims to answer are: * which changes in bowel environment can the sensor pill measure in ulcerative colitis and colorectal cancer before and after treatment? * how practical, effective and user-friendly is the sensor pill for measuring bowel environment in patients with bowel disease? Participants will: * take one sensor pill before treatment and take one sensor pill three months after (start of) treatment; * monitor sensor pill bowel exit using a small wearable device; * answer a questionnaire on experience with the sensor pill; * receive an extra bowel ultrasound (non-endoscopic) three months after start of treatment (only for participants with ulcerative colitis).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ (For all participants:)

• Age ≥ 18 years old;

• willing and able to provide informed consent;

• defaecation pattern: generally at least one defaecation per 48 hours.

⁃ (For the UC group:)

• Diagnosis of UC confirmed by clinical, endoscopic, and/or histological evidence prior to screening as per standard criteria;

• moderately to severely active UC determined by intestinal ultrasound (bowel wall thickness (BWT) \> 3 mm), starting treatment or requiring change in treatment due to non-response to their existing treatment;

• starting or optimizing treatment for colitis (including aminosalicylates, oral corticosteroids, thiopurines, biologics and small molecules).

⁃ (For the CRC group:)

• Diagnosis of non-obstructing non-locally advanced colorectal adenocarcinoma;

• ready/planned for surgery of CRC.

Locations
Other Locations
Netherlands
Radboud university medical center
RECRUITING
Nijmegen
Contact Information
Primary
Lotte R Hazeleger, Master of Science
lotte.hazeleger@radboudumc.nl
+31650008309
Backup
Marjolijn Duijvestein, MD PhD
marjolijn.duijvestein@radboudumc.nl
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 10
Treatments
Ulcerative colitis
Colorectal cancer
Sponsors
Collaborators: Stichting IMEC-NL
Leads: Radboud University Medical Center

This content was sourced from clinicaltrials.gov