Smart swallowable pill to measure gut oxidation in colon inflammation and cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational pilot that uses an ingestible sensor capsule to measure intestinal oxidation-reduction potential (ORP) in adults with ulcerative colitis (UC) or non-obstructing colorectal cancer (CRC). Participants will swallow one sensor pill before starting or changing treatment and a second pill three months after treatment begins, while wearing a small device to monitor capsule passage and completing a brief user-experience questionnaire. For UC participants only, a non-endoscopic bowel ultrasound will be performed three months after treatment to compare with ORP measurements. The study enrolls five patients with UC and five with CRC and does not alter medical or surgical therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Radboud university medical center
  Nijmegen, Gelderland, Netherlands Recruiting

Study contacts

• Principal investigator: Marjolijn Duijvestein, MD PhD — Radboud University Medical Center
• Study coordinator: Lotte R Hazeleger, Master of Science
• Email: lotte.hazeleger@radboudumc.nl
• Phone: +31650008309

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.