Crohn Disease
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTModulen
Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet
DRUGBudesonide
Standard treatment for mild Crohn Disease patients
Sponsors
Hillel Yaffe Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed Crohn's Disease * Mild to moderate severity
Exclusion criteria
* Patients who received systemic steroid or Budesonide or biological treatment * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Modulen Diet | 8 weeks | 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. |
Countries
Israel
Contacts
Primary ContactBaruch Ovadia, MD
Outcome results
None listed