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The aim of this study is to evaluate prospectively a possible effect of an oral polymeric diet enriched with TGF-beta 2 (Modulen) as compared to Budesonide (one of the commonly accepted treatments for Crohn's disease) on clinical response, mucosal healing and intestinal microbiota in adult patients with newly diagnosed Crohn's disease using a capsule endoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modulen Diet | Active Comparator | Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet |
|
| Budesonide Treatment | Active Comparator | Crohn patients will be given Budesonide treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modulen | Dietary Supplement | Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Modulen Diet | Patients will undergo capsular endoscopy before and after dietary intervention and mucosal healing will be accessed using standard Lewis Score. Outcome will be compared to efficacy of Budesonide treatment. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baruch Ovadia, MD | Contact | 972-545767372 | ovadiabaruch@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Baruch Ovadia, MD | Hillel Yaffe Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillel Yaffe Medical Center | Hadera | 38100 | Israel |
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| Budesonide | Drug | Standard treatment for mild Crohn Disease patients |
|
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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