SPIRIT

Measurement of oxidation reduction potential in the colon using an ingestible sensor in patients with inflammatory bowel disese (IBD) and colorectal cancer (CRC) - SPIRIT

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57338

Enrollment

Registered

2024-11-15

Start date

2025-07-01

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colon cancer, colorectal carcinoma, ulcerative colitis, crohn's disease colon cancer, inflammatory bowel disease

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - age >= 18 years - diagnosed with colorectal cancer and planned for surgerical tumour resection  OR  - diagnosed with IBD, with active inflammation as determined by increased bowel wall thickness on intestinal ultrasound

Exclusion criteria

Exclusion criteria: - BMI > 30 kg/m2 - 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. - Pregnant, lactating or trying to get pregnant - Pacemaker or other implantable electronic devices

Design outcomes

Primary

Measure	Time frame
- Measurement of ORP profile in the colon using the GISMO GEN1 System in patients with IBD or CRC before and after treatment. - To relate intestinal ORP profile in the colon to known tumor location or area of inflammation, for respectively CRC and IBD. - To compare intestinal ORP and pH profiles before and after medical treatment or surgical resection for respectively IBD and CRC. - To relate intestinal ORP profile to measures of disease activity in IBD, including fecal calprotectin (FC). - To compare intestinal ORP and pH profiles of IBD and CRC patients to those of healthy controls. - To relate intestinal ORP profile to prevalence of (an)aerobic activity of IBD patients using microbiome analyses. - To continue assessment of the feasibility of the GISMO GEN1 System in humans with GI tract related disorders by studying the ingestible transit time, data coverage, partici-pant experience, and serious adverse events (if applicable).	—

Measure

Time frame

- Measurement of ORP profile in the colon using the GISMO GEN1 System in patients with IBD or CRC before and after treatment. - To relate intestinal ORP profile in the colon to known tumor location or area of inflammation, for respectively CRC and IBD. - To compare intestinal ORP and pH profiles before and after medical treatment or surgical resection for respectively IBD and CRC. - To relate intestinal ORP profile to measures of disease activity in IBD, including fecal calprotectin (FC). - To compare intestinal ORP and pH profiles of IBD and CRC patients to those of healthy controls. - To relate intestinal ORP profile to prevalence of (an)aerobic activity of IBD patients using microbiome analyses. - To continue assessment of the feasibility of the GISMO GEN1 System in humans with GI tract related disorders by studying the ingestible transit time, data coverage, partici-pant experience, and serious adverse events (if applicable).  

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Countries

Netherlands

Contacts

Public ContactLR Hazeleger

Radboud Universitair Medisch Centrum

bedrijfsondersteuningmdl@radboudumc.nl0243616999

Outcome results