Smart Pill for Measuring Gut Health in Colon Inflammation and Colon Cancer
Recruiting · NCT07046468 · Observational (researchers observe without assigning treatment) · Lead sponsor: Radboud University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
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).
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- For all participants:)
- Body mass index (BMI) \> 30 kg/m\^2;
- known obstruction, stricture or stenosis in the gastrointestinal tract not attributable to current inflammation or tumour, potentially blocking ingestible passage. Determined as per discretion of gastroenterologist/oncologist using standard procedural clinical diagnostic or imaging techniques;
- history of complex bowel resection or recent intra-abdominal surgery (\< 3 months);
- known abdominal adhesions;
- swallowing disorders, including achalasia or oropharyngeal dysfunction;
- ongoing infections;
- known to be pregnant, lactating or actively trying to get pregnant (self-reported);
- short bowel syndrome or ostomy;
- only parenteral diet;
- pacemaker or other implantable electronic devices;
- planned magnetic resonance imaging (MRI) procedure during the ingestible meaurement period;
- unwilling to undergo an X-ray examination (in the case ingestible exit cannot be confirmed);
- participation in other medical interventional/Wet medisch-wetenschappelijk onderzoek (WMO)-compliant reearch;
- participant is working (as medical personnel) in a professional healthcare facility (intensive care, emergency room, surgery rooms, clinics, patient rooms), military area (e.g. submarine, near radar installation), or heavy industrial area (e.g. power plants, automotive, mining, refineries) during the duration of the clinical investigation.
- For the CRC group:)
- Diagnosis or strong suspicion of IBD;
- planned treatment with adjuvant chemotherapy or radiotherapy.
- For the UC population:)
- Diagnosis or strong suspicion of colorectal adenocarcinoma;
- use of rectal foam/enema during the measurement period.
Where it is running
1 location listed.
- Radboud university medical center - Nijmegen, Gelderland, Netherlands