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NCT04233463 Clinical Trial

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

Crohn Disease Clinical Trial

Official title:
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: a Prospective, Randomized Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04233463
Other study ID # 0128-18-HYMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2020
Est. completion date June 2021

Study information
Verified date January 2020
Source Hillel Yaffe Medical Center
Contact Baruch Ovadia, MD
Phone 972-545767372
Email ovadiabaruch@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date June 2021
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Modulen
Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet
Drug:
• Budesonide
Standard treatment for mild Crohn Disease patients

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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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