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

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Crohn Disease

Treatments: Dietary Supplement: Modulen; Drug: Budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT04233463

0128-18-HYMC

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Modulen Diet

Active Comparator group

Description:

Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet

Treatment:

Dietary Supplement: Modulen

Budesonide Treatment

Active Comparator group

Description:

Crohn patients will be given Budesonide treatment

Treatment:

Drug: Budesonide