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
- Registration Number
- NCT04233463
- Lead Sponsor
- Hillel Yaffe Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Modulen Diet Modulen Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet Budesonide Treatment Budesonide Crohn patients will be given Budesonide treatment
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hillel Yaffe Medical Center
🇮🇱Hadera, Israel