Smart Pill for Measuring Gut Health in Colon Inflammation and Colon Cancer

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new “smart pill” that can be swallowed to help measure changes inside the gut for people with ulcerative colitis (a type of long-term bowel inflammation) or colorectal cancer. The pill contains a tiny sensor that collects information about the bowel environment before and after treatment. Researchers want to see if this pill can help doctors better understand these conditions and how well treatments are working. They also want to know if using the pill is safe, easy, and comfortable for patients.

Adults 18 years and older who have either moderate to severe ulcerative colitis starting or changing treatment, or colorectal cancer that is ready for surgery may be able to take part. During the study, participants will swallow the sensor pill twice—once before treatment and once three months after treatment begins. They will wear a small device to track when the pill leaves their body and answer questions about their experience with the pill. People with ulcerative colitis will also have a special bowel ultrasound three months after treatment starts, which is a painless scan that looks at the bowel from outside the body. Some health conditions, such as severe obesity, certain surgeries, or implanted electronic devices, may prevent someone from joining. This study is not yet recruiting participants.

Gender

ALL

Eligibility criteria

• 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.