Ulcerative Colitis (UC)SPIRITNCT07046468
Smart Pill for Measuring Gut Health in Colon Inflammation and Colon Cancer
An observational study of Ulcerative Colitis (UC) and Colorectal Cancer (CRC), run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (UC), Colorectal Cancer (CRC)
- What is being tested?
- Ingestion of sensor capsule (twice), Device evaluation questionnaire and Wearing device
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2025to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will be performed in outpatients ≥18 years old. Five patients will be included with moderately to severely active UC, starting new treatment; five patients with colorectal adenocarcinoma, planned for surgery.
Who may be able to join
- (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;
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- 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 cannot join
- (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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marjolijn Duijvestein, MD PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Radboud university medical center
Nijmegen, Gelderland, 6525GA
Lotte R Hazeleger, Master of Science, +31243616999, lotte.hazeleger@radboudumc.nl
Marjolijn Duijvestein, MD PhD, +31243616999, marjolijn.duijvestein@radboudumc.nl
About this study
Official title: Measurement of Oxidation Reduction Potential in the Colon Using an Ingestible Sensor in Patietns With Ulcerative Colitis (UC) and Colorectal Cancer (CRC)
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?
Read more
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).
Read the detailed description
Rationale: The gold standard diagnostic tool for inflammatory bowel disease (IBD) and colorectal carcinoma (CRC) is endoscopy, which can be burdensome for patients. The future of IBD care demands novel, minimally invasive biomarkers for personalized care and CRC screening programs could greatly benefit from new minimally invasive diagnostic tools. Oxidative stress plays a significant role in the progression of gut inflammation and colorectal cancer. Using an ingestible sensor, we aim to measure oxidation-reduction potential (ORP) directly in the gut. We hypothesize that it is feasible to measure intestinal ORP with an ingestible sensor and expect that ORP levels are elevated in patients with active ulcerative colitis (UC) and CRC before treatment, compared to after treatment.
Objective: Measurement of intestinal oxidation-reduction potential using a smart sensing ingestible and its relation to active UC and CRC.
Study design: Observational, exploratory study with invasive measurements.
Study population: 5 patients ≥ 18 years of age with UC and 5 patients ≥ 18 years of age with CRC
Main study parameters/endpoints: The main study parameter is colonic ORP profiles measured with the ingestible sensor ingestible compared before and after treatment for UC and CRC.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Risk associated with participation are deemed low. Medical or surgical treatment is not altered in any way. Patients with UC will receive an additional IUS. The GISMO GEN1 ingestible device (size 21.8 mm x 7.64 mm) is an investigational tool deemed safe for human use in clinical settings, with risks detailed in the IMDD. Device exit will be tracked via the temperature sensor of the ingestible sensor. If exit is not confirmed after 14 days, an X-ray will confirm whether the device is still in the gastrointestinal tract. If visible on the X-ray, a medical specialist will determine further action, which may include laxatives or surgery, with costs covered by the research team. If X-ray examination is necessary, the participant may experience a maximum radiation exposure of 0.10 mSv. Participant burden is low; time investment including study visits, device checks and questionnaire is estimated around 4 hours in total. Main burden is expected to be the continuous wearing of the base device as long as the ingestible sensor remains in the body.
- Conditions
- Ulcerative Colitis (UC), Colorectal Cancer (CRC)
- Being tested
- Ingestion of sensor capsule (twice), Device evaluation questionnaire, Wearing device, Monitoring sensor capsule exit, Placement of devices at home
- Keywords
- Ulcerative Colitis, Colorectal cancer, Sensor, Redox, Oxidation reduction potential, Ingestible, Sensor pill, Inflammatory bowel disease
- Medical subject headings
- Colitis, Ulcerative, Colorectal Neoplasms, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingestion of sensor capsule (twice)Device
Also called GISMO GEN1 System
Ingestion of the GISMO GEN1 System, an ingestible sensor capsule which measures pH, temperature and oxidation reduction potential (ORP) in the intestines.
Device evaluation questionnaireBehavioural
A 16-item online questionnaire to assess participant's experiences with the ingestible sensor capsule after the study measurements.
Wearing deviceDevice
Participants will wear a small device on a soft belt around their waist during study measurements with the sensor capsules.
Monitoring sensor capsule exitBehavioural
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.
Placement of devices at homeDevice
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 ultrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative colitis | Not described Receives: Device: Ingestion of sensor capsule (twice); Behavioral: Device evaluation questionnaire; Device: Wearing device; Behavioral: Monitoring sensor capsule exit; Device: Placement of devices at home; Diagnostic Test: Follow-up intestinal ultrasound | |
| Colorectal cancer | Not described Receives: Device: Ingestion of sensor capsule (twice); Behavioral: Device evaluation questionnaire; Device: Wearing device; Behavioral: Monitoring sensor capsule exit; Device: Placement of devices at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal ORP measurements
ORP profile in the colon using the GISMO GEN1 System in patients with UC or CRC.
Measured: Baseline and at 3 months after start of treatment.
Disease activity (SCCAI)
UC disease activity as determined by the Simple Clinical Colitis Activity Index
Measured: Baseline and 3 months after start of treatment.
Disease activity (FC)
UC disease activity as determined by the faecal calprotectin (in microgram/gram)
Measured: Baseline and at 3 months after treatment start.
Tumor stage
TNM tumor stage as recorded in pathology report.
Measured: Directly after surgical resection
Tumor size
Tumor size as recorded in surgery report.
Measured: Directly after surgical resection
Tumor resection margin status
Residual tumor at the primary site after surgical resection as classified in pathology report.
Measured: Directly after surgical resection
Tumor differentiation grade
Tumor differentiation grade as recorded in pathology report.
Measured: Directly after surgical resection
Secondary outcomes (6)
Intestinal pH
Intestinal pH measured with the ingestible sensor capsule.
Measured: From enrollment to 3 months after start of treatment.
Area of inflammation
Area of inflammation in patients with UC, as recorded in the intestinal ultrasound report.
Measured: Directly after intestinal ultrasound.
Tumour location
Tumor location in patients with CRC as recorded in the surgery report.
Measured: Directly post-surgery.
Ingestible transit time.
Time from ingestion to defaecation in hours.
Measured: Baseline and at 3 months after start of treatment.
Data coverage
Data coverage of recordings with the ingestible sensor capsule in minutes of data recorded as percentage of transit time in minutes (%)
Measured: Baseline and at 3 months after start of treatment
Participant experience
Participant experience determined with a satisfaction questionnaire.
Measured: Up to 1 month after exit of the post-treatment ingestible sensor capsule measurement period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jul 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting IMEC-NL
- Responsible party
- Sponsor
- Investigators
- Marjolijn Duijvestein, MD PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046468
- Sponsor's protocol ID
- 2024-17771
- Other IDs
- NL88151.091.24
- Acronym
- SPIRIT
- Status last verified
- Feb 2025
- First submitted
- 26 Mar 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that supports the findings of this study can be made available upon request to the corresponding author within the regulations of the applicable regulations and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- SPIRIT / 2024-17771
- Conditions
- Ulcerative Colitis (UC), Colorectal Cancer (CRC)
- Keywords
- Ulcerative Colitis, Colorectal cancer, Sensor, Redox, Oxidation reduction potential, Ingestible, Sensor pill, Inflammatory bowel disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Stichting IMEC-NL
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Rationale: The gold standard diagnostic tool for inflammatory bowel disease (IBD) and colorectal carcinoma (CRC) is endoscopy, which can be burdensome for patients. The future of IBD care demands novel, minimally invasive biomarkers for personalized care and CRC screening programs could greatly benefit from new minimally invasive diagnostic tools. Oxidative stress plays a significant role in the progression of gut inflammation and colorectal cancer. Using an ingestible sensor, we aim to measure oxidation-reduction potential (ORP) directly in the gut. We hypothesize that it is feasible to measure intestinal ORP with an ingestible sensor and expect that ORP levels are elevated in patients with active ulcerative colitis (UC) and CRC before treatment, compared to after treatment.
Objective: Measurement of intestinal oxidation-reduction potential using a smart sensing ingestible and its relation to active UC and CRC.
Study design: Observational, exploratory study with invasive measurements.
Study population: 5 patients ≥ 18 years of age with UC and 5 patients ≥ 18 years of age with CRC
Main study parameters/endpoints: The main study parameter is colonic ORP profiles measured with the ingestible sensor ingestible compared before and after treatment for UC and CRC.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Risk associated with participation are deemed low. Medical or surgical treatment is not altered in any way. Patients with UC will receive an additional IUS. The GISMO GEN1 ingestible device (size 21.8 mm x 7.64 mm) is an investigational tool deemed safe for human use in clinical settings, with risks detailed in the IMDD. Device exit will be tracked via the temperature sensor of the ingestible sensor. If exit is not confirmed after 14 days, an X-ray will confirm whether the device is still in the gastrointestinal tract. If visible on the X-ray, a medical specialist will determine further action, which may include laxatives or surgery, with costs covered by the research team. If X-ray examination is necessary, the participant may experience a maximum radiation exposure of 0.10 mSv. Participant burden is low; time investment including study visits, device checks and questionnaire is estimated around 4 hours in total. Main burden is expected to be the continuous wearing of the base device as long as the ingestible sensor remains in the body.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitis | – | Device: Ingestion of sensor capsule (twice), Behavioral: Device evaluation questionnaire, Device: Wearing device, Behavioral: Monitoring sensor capsule exit, Device: Placement of devices at home, Diagnostic Test: Follow-up intestinal ultrasound |
| Colorectal cancer | – | Device: Ingestion of sensor capsule (twice), Behavioral: Device evaluation questionnaire, Device: Wearing device, Behavioral: Monitoring sensor capsule exit, Device: Placement of devices at home |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be performed in outpatients ≥18 years old. Five patients will be included with moderately to severely active UC, starting new treatment; five patients with colorectal adenocarcinoma, planned for surgery.
Key inclusion criteria (11 listed)
- (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:)
Key exclusion criteria (21 listed)
- (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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ingestion of sensor capsule (twice)Also: GISMO GEN1 SystemIngestion of the GISMO GEN1 System, an ingestible sensor capsule which measures pH, temperature and oxidation reduction potential (ORP) in the intestines. | Device | Colorectal cancer, Ulcerative colitis |
| Device evaluation questionnaireA 16-item online questionnaire to assess participant's experiences with the ingestible sensor capsule after the study measurements. | Behavioural | Colorectal cancer, Ulcerative colitis |
| Wearing deviceParticipants will wear a small device on a soft belt around their waist during study measurements with the sensor capsules. | Device | Colorectal cancer, Ulcerative colitis |
| Monitoring sensor capsule exitParticipants 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. | Behavioural | Colorectal cancer, Ulcerative colitis |
| Placement of devices at homeParticipants 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. | Device | Colorectal cancer, Ulcerative colitis |
| Follow-up intestinal ultrasoundAt 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. | Diagnostic test | Ulcerative colitis |
Primary outcome
Intestinal ORP measurements
Time frame: Baseline and at 3 months after start of treatment.
ORP profile in the colon using the GISMO GEN1 System in patients with UC or CRC.
Disease activity (SCCAI)
Time frame: Baseline and 3 months after start of treatment.
UC disease activity as determined by the Simple Clinical Colitis Activity Index
Disease activity (FC)
Time frame: Baseline and at 3 months after treatment start.
UC disease activity as determined by the faecal calprotectin (in microgram/gram)
Tumor stage
Time frame: Directly after surgical resection
TNM tumor stage as recorded in pathology report.
Tumor size
Time frame: Directly after surgical resection
Tumor size as recorded in surgery report.
Tumor resection margin status
Time frame: Directly after surgical resection
Residual tumor at the primary site after surgical resection as classified in pathology report.
Tumor differentiation grade
Time frame: Directly after surgical resection
Tumor differentiation grade as recorded in pathology report.
6 secondary outcomes
Intestinal pH
Time frame: From enrollment to 3 months after start of treatment.
Area of inflammation
Time frame: Directly after intestinal ultrasound.
Tumour location
Time frame: Directly post-surgery.
Ingestible transit time.
Time frame: Baseline and at 3 months after start of treatment.
Data coverage
Time frame: Baseline and at 3 months after start of treatment
Participant experience
Time frame: Up to 1 month after exit of the post-treatment ingestible sensor capsule measurement period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No. The data that supports the findings of this study can be made available upon request to the corresponding author within the regulations of the applicable regulations and ethical considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marjolijn Duijvestein, MD PhD contact
Marjolijn Duijvestein, MD PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis (UC) and Colorectal Cancer (CRC), run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lotte R Hazeleger, Master of Science (+31650008309, lotte.hazeleger@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal ORP measurements (time frame: Baseline and at 3 months after start of treatment.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.