Actively Recruiting
Smart Pill for Measuring Gut Health in Colon Inflammation and Colon Cancer
Led by Radboud University Medical Center · Updated on 2025-08-29
10
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
S
Stichting IMEC-NL
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Smart Pill for Measuring Gut Health in Colon Inflammation and Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Willing and able to provide informed consent
- Generally have at least one bowel movement every 48 hours
- For ulcerative colitis group: confirmed diagnosis of ulcerative colitis by clinical, endoscopic, or histological evidence
- For ulcerative colitis group: moderately to severely active ulcerative colitis with bowel wall thickness over 3 mm by ultrasound
- For ulcerative colitis group: starting or changing treatment for colitis
- For colorectal cancer group: diagnosis of non-obstructing, non-locally advanced colorectal adenocarcinoma
- For colorectal cancer group: planned surgery for colorectal cancer
You will not qualify if you...
- Body mass index (BMI) greater than 30 kg/m²
- Known obstruction, stricture, or stenosis in the gastrointestinal tract that might block the sensor pill
- History of complex bowel surgery or abdominal surgery within past 3 months
- Known abdominal adhesions
- Swallowing disorders such as achalasia or oropharyngeal dysfunction
- Ongoing infections
- Known pregnancy, breastfeeding, or actively trying to become pregnant
- Short bowel syndrome or having an ostomy
- Only receiving parenteral nutrition
- Having a pacemaker or other implantable electronic devices
- Planned MRI during the sensor pill measurement period
- Unwillingness to have an X-ray if needed to confirm sensor pill exit
- Participation in other medical intervention studies
- Working as medical personnel in certain healthcare, military, or industrial high-risk areas during the study
- For colorectal cancer group: diagnosis or strong suspicion of inflammatory bowel disease
- For colorectal cancer group: planned chemotherapy or radiotherapy
- For ulcerative colitis group: diagnosis or strong suspicion of colorectal adenocarcinoma
- For ulcerative colitis group: use of rectal foam or enema during the measurement period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Radboud university medical center
Nijmegen, Gelderland, Netherlands, 6525GA
Actively Recruiting
Research Team
L
Lotte R Hazeleger, Master of Science
CONTACT
M
Marjolijn Duijvestein, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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