GI Fluids Collection for an Ex-Vivo Development of Ingestible Capsule Devices With Real Time Biosensors

Study Overview
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Brief Summary
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Up to 500 subjects undergoing standard endoscopy / pouchoscopy, or having ileostomy or colostomy bags or having an ileal pouch and who meet the eligibility criteria will be enrolled to this study during up to three years at up to 4 clinical sites. GI fluids samples will be collected from: (i) fluids suctioned during standard endoscopy procedures / pouchoscopy, (ii) from ileostomy/colostomy bags removed for bag replacement and (iii) from stool samples collected by patients after pouch surgery.

Detailed Description
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Up to 500 subjects undergoing standard endoscopy / pouchoscopy, or having ileostomy or colostomy bags or having an ileal pouch and who meet the eligibility criteria will be enrolled to this study during up to three years at up to 4 clinical sites. GI fluids samples will be collected from: (i) fluids suctioned during standard endoscopy procedures / pouchoscopy, (ii) from ileostomy/colostomy bags removed for bag replacement and (iii) from stool samples collected by patients after pouchsurgery. The samples will be collected into sealed plastic containers, clearly labeled with Biohazard stickers and patient's code and be kept on ice for up to 30min and then freezed in -20deg to -80deg. Characterization and quanification of small molecules- and protein biomarkers of GI diseases such as IBD will be performed.

Official Title
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GI Fluids Collection for an Ex-Vivo Development of Ingestible Capsule Devices With Real Time Biosensors

Conditions
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Chronic Inflammatory Small Bowel Disease

Intervention / Treatment
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* Procedure: Endoscopy procedures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects ages 18-75 years Subjects referred to endoscopic procedures gastroscopy, esophagogastroduodenoscopy (EGD), colonoscopy, single balloon or double balloon enteroscopy Or Subjects having ileostomy or colostomy bags Or Subjects having an ileal pouch Subjects agree to sign consent form Exclusion Criteria: Patients has any medical condition that requires special handling of body fluids beyond routine infection control measures (i.e. standard surgical gloves)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GI fluids samples collection<br>GI fluids samples will be collected from: (i) fluids suctioned during standard endoscopy procedures / pouchoscopy, (ii) from ileostomy/colostomy bags removed for bag replacement and (iii) from stool samples collected by patients after pouch surgery. | Procedure: Endoscopy procedures<br>* GI fluids samples will be collected from: (i) fluids suctioned during standard endoscopy procedures / pouchoscopy, (ii) from ileostomy/colostomy bags removed for bag replacement and (iii) from stool samples collected by patients after pouch surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization and quantification of small molecules- and protein biomarkers of GI diseases will be performed. Examples of such biomarkers include - calprotectin, lactoferrin, albumin, hemoglobin, CEA, CA19-9, CA 72-4, LYVE-1, REG1A, TFF1 and ammonia. | The concentration of the biomarkers in the collected fluids from different parts of the GI will be determined by quantitative assays - such as ELISA or lateral flow immunoassay or mass spectrometry. Concentration will be determined in mg/ml. | 3 years |