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

Prior treatment

• 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:)
• planned treatment with adjuvant chemotherapy or radiotherapy.
  • (For the UC population:)

Other illness

• history of complex bowel resection or recent intra-abdominal surgery (\< 3 months);
• swallowing disorders, including achalasia or oropharyngeal dysfunction;
• ongoing infections;
• short bowel syndrome or ostomy;

Other

• (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;
• known abdominal adhesions;
• known to be pregnant, lactating or actively trying to get pregnant (self-reported);
• 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;
• Diagnosis or strong suspicion of IBD;
• Diagnosis or strong suspicion of colorectal adenocarcinoma;
• use of rectal foam/enema during the measurement period.

• (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.