NCT07046468

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Rationale: The gold standard diagnostic tool for inflammatory bowel disease (IBD) and colorectal carcinoma (CRC) is endoscopy, which can be burdensome for patients. The future of IBD care demands novel, minimally invasive biomarkers for personalized care and CRC screening programs could greatly benefit from new minimally invasive diagnostic tools. Oxidative stress plays a significant role in the progression of gut inflammation and colorectal cancer. Using an ingestible sensor, we aim to measure oxidation-reduction potential (ORP) directly in the gut. We hypothesize that it is feasible to measure intestinal ORP with an ingestible sensor and expect that ORP levels are elevated in patients with active ulcerative colitis (UC) and CRC before treatment, compared to after treatment. Objective: Measurement of intestinal oxidation-reduction potential using a smart sensing ingestible and its relation to active UC and CRC. Study design: Observational, exploratory study with invasive measurements. Study population: 5 patients ≥ 18 years of age with UC and 5 patients ≥ 18 years of age with CRC Main study parameters/endpoints: The main study parameter is colonic ORP profiles measured with the ingestible sensor ingestible compared before and after treatment for UC and CRC. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Risk associated with participation are deemed low. Medical or surgical treatment is not altered in any way. Patients with UC will receive an additional IUS. The GISMO GEN1 ingestible device (size 21.8 mm x 7.64 mm) is an investigational tool deemed safe for human use in clinical settings, with risks detailed in the IMDD. Device exit will be tracked via the temperature sensor of the ingestible sensor. If exit is not confirmed after 14 days, an X-ray will confirm whether the device is still in the gastrointestinal tract. If visible on the X-ray, a medical specialist will determine further action, which may include laxatives or surgery, with costs covered by the research team. If X-ray examination is necessary, the participant may experience a maximum radiation exposure of 0.10 mSv. Participant burden is low; time investment including study visits, device checks and questionnaire is estimated around 4 hours in total. Main burden is expected to be the continuous wearing of the base device as long as the ingestible sensor remains in the body.

Conditions

• Ulcerative Colitis (UC)
• Colorectal Cancer (CRC)

Interventions

Type	Name	Description
DEVICE	Ingestion of sensor capsule (twice)	Ingestion of the GISMO GEN1 System, an ingestible sensor capsule which measures pH, temperature and oxidation reduction potential (ORP) in the intestines.
BEHAVIORAL	Device evaluation questionnaire	A 16-item online questionnaire to assess participant's experiences with the ingestible sensor capsule after the study measurements.
DEVICE	Wearing device	Participants will wear a small device on a soft belt around their waist during study measurements with the sensor capsules.
BEHAVIORAL	Monitoring sensor capsule exit	Participants are instructed to press a button on the wearable device when they use the toilet for defaecation and wait with flushing to toilet until the wearable device indicates (using colored LEDs) that the toilet can be flushed and 1) that the sensor capsule is still in the body and study measurements continue or 2) that the sensor capsule has likely been excreted via the feces and the participant has to contact the research team to confirm exit.
DEVICE	Placement of devices at home	Participants do not have to wear the device around the waist during sleeping. For optimal monitoring of sensor capsule exit during the nights, a second device will be placed on the participant's bedside table/close to the bed and a third device will be placed close to the toilet that the participant usually uses during the night.
DIAGNOSTIC_TEST	Follow-up intestinal ultrasound	At 3 months after treatment initiation, participants with ulcerative colitis will undergo a follow-up intestinal ultrasound (IUS) (non-endoscopic) outside of routine care to assess treatment response.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2025-07-01
• Last updated: 2025-08-29

Locations

1 site across 1 country: Netherlands