Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients

Study Overview
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Brief Summary
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The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients, using the PillCam Colon system.

Detailed Description
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Primary Scientific Objective Evaluate the effectiveness of the PillCam COLON 2 Prep Regimen in CD patients. Secondary Objective To evaluate safety of the PillCam™ COLON 2 procedure in CD patients Study Hypothesis Crohn's Disease may be pan-enteric in nature and can affect the small bowel, the colon or both. PillCam COLON 2 may be used for visualization of both SB and colon mucosa in Crohn's Disease patients. However, bowel prep is required in order to evacuate all fecal matter prior to the exam and in order to propel the capsule and complete its traverse through the entire GI track within examination time. The study is designed to evaluate the effectiveness of the prep regimen in terms of transit, excretion and cleansing in CD patients All end points will be evaluated within 4 months from end of enrollment.

Official Title
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Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients- Pivotal Study

Conditions
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Crohn's Disease

Intervention / Treatment
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* Other: bowel prep regimen first boost 6 oz. and second boost 3 oz.
* Other: bowel prep regimen first boost 3 oz. and second boost 6 oz.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 years of age and above Subjects who are determined by their physician to have active Crohn's disease based on at least one of the following tests which were performed in the past 3 months : Colonoscopy Capsule endoscopy of the small bowel or colon Other radiology tests Clinical symptoms with elevated positive inflammatory markers ;ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, or fecal alpha-1 antitrypsin Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 3 months prior to enrollment Subject is able and agrees to sign the Informed Consent Form Exclusion Criteria: • Subject has dysphagia Subject has congestive heart failure Subject has renal insufficiency Subject has cirrhosis Subject is known or is suspected to suffer from intestinal obstruction Subject has known previous stricture/obstruction of the SB or colon Chronic use of laxatives Subject has a cardiac pacemaker or other implanted electro medical device. Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule. Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator. Subject has any condition, which precludes compliance with study and/or device instructions. Subject suffers from life threatening conditions Subject is currently participating in another clinical study Subject has known slow gastric emptying time or GI transit time. Subject is allergic or contraindicated to any of the study medications

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: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bowel prep regimen first boost 6 oz. and second boost 3 oz.<br>4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI | Other: bowel prep regimen first boost 6 oz. and second boost 3 oz.<br>* Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)<br>|
| Experimental: bowel prep regimen first boost 3 oz. and second boost 6 oz.<br>4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI | Other: bowel prep regimen first boost 3 oz. and second boost 6 oz.<br>* Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Evaluate the Effectiveness of the PillCam COLON 2 Bowel Prep Regimen in Crohn's Disease Patients | effectiveness of the PillCam COLON 2 bowel prep regimen in Crohn's Disease patients will be evaluated by the folloiwng: • Bowel preparation cleansing level assessment The duration of the procedure in this study is 1 day of colon preparation and 1 day of Capsule Endoscopy (CE) procedure. 5-9 days after the CE procedure a follow up call to the subjects will be conducted. | The end points and outcomes measures will be evaluated within 4 months from end of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Known, active Crohn's disease, Iieocolonic or colonic involvement, proven patency of the GI tract