RECRUITINGOBSERVATIONAL

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)

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: (For all participants:) - Age ≥ 18 years old; - willing and able to provide willing to sign a consent form; - 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. Who Should NOT Join This Trial: (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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (1)

Radboud university medical center

Nijmegen, Gelderland, Netherlands