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

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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Stichting IMEC-NL

  collaborator OTHER

• Radboud University Medical Center

  lead OTHER

Principal Investigators

• Marjolijn Duijvestein, MD PhD · Radboud University Medical Center

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2026-03-01

Completion

2026-05-01

Countries

• Netherlands

Study Locations