UCRecruiting
Smart Pill for Measuring Gut Health in Colon Inflammation and Colon Cancer
Observational · No treatment assigned · 1 site · Radboud University Medical Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis (UC) and Colorectal Cancer (CRC). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- (For all participants:)
- Age ≥ 18 years old;
- willing and able to provide informed consent;
Plus 8 more requirement(s). There are also 21 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 10 participants are expected to take part.
- Start date: 2025-07-01.
- Main results expected around 2026-03-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Netherlands.
Main thing being measured
- Intestinal ORP measurements (Baseline and at 3 months after start of treatment.)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis (UC); Colorectal Cancer (CRC) |
| Lead sponsor | Radboud University Medical Center |
| Collaborators | Stichting IMEC-NL |
| Enrollment | 10 (estimated) |
| Start date | 2025-07-01 |
| Primary completion (est.) | 2026-03-01 |
| First posted | 2025-07-01 |
| Last updated | 2025-08-29 |
| Official title | Measurement of Oxidation Reduction Potential in the Colon Using an Ingestible Sensor in Patietns With Ulcerative Colitis (UC) and Colorectal Cancer (CRC) |
| ClinicalTrials.gov ID | NCT07046468 |
Interventions
- Ingestion of sensor capsule (twice) (Device)
Ingestion of the GISMO GEN1 System, an ingestible sensor capsule which measures pH, temperature and oxidation reduction potential (ORP) in the intestines. - Device evaluation questionnaire (Behavioral)
A 16-item online questionnaire to assess participant's experiences with the ingestible sensor capsule after the study measurements. - Wearing device (Device)
Participants will wear a small device on a soft belt around their waist during study measurements with the sensor capsules. - Monitoring sensor capsule exit (Behavioral)
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 particip… - Placement of devices at home (Device)
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. - Follow-up intestinal ultrasound (Diagnostic Test)
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.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Radboud university medical center | Nijmegen, Gelderland | Netherlands | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.