The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease
NCT ID: NCT04233463
Last Updated: 2020-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-01-31
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Modulen Diet
Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet
Modulen
Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet
Budesonide Treatment
Crohn patients will be given Budesonide treatment
Budesonide
Standard treatment for mild Crohn Disease patients
Interventions
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Modulen
Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet
Budesonide
Standard treatment for mild Crohn Disease patients
Eligibility Criteria
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Inclusion Criteria
* Mild to moderate severity
Exclusion Criteria
* Recent bowel surgery
* Colostomy, ileostomy
* Short bowel syndrome
* Obstructive symptoms
* Pregnancy, lactation
* Cardiac pacemaker or defibrillator
* Swallowing problems
* Uncontrolled metabolic diseases or any other condition that can be exacerbated by steroids
18 Years
70 Years
ALL
No
Sponsors
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Hillel Yaffe Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Baruch Ovadia, MD
Role: PRINCIPAL_INVESTIGATOR
Hillel Yaffe Medical Center
Locations
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Hillel Yaffe Medical Center
Hadera, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0128-18-HYMC
Identifier Type: -
Identifier Source: org_study_id
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