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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

Primary Purpose

Crohn Disease

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Modulen
Budesonide
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Modulen Diet

Budesonide Treatment

Arm Description

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

Crohn patients will be given Budesonide treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2020
Last Updated
January 15, 2020
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04233463
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modulen Diet
Arm Type
Active Comparator
Arm Description
Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet
Arm Title
Budesonide Treatment
Arm Type
Active Comparator
Arm Description
Crohn patients will be given Budesonide treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Modulen
Intervention Description
Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
Standard treatment for mild Crohn Disease patients
Primary Outcome Measure Information:
Title
Efficacy of Modulen Diet
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baruch Ovadia, MD
Phone
972-545767372
Email
ovadiabaruch@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baruch Ovadia, MD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baruch Ovadia, MD
Phone
972-545767372
Email
ovadiabaruch@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this 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

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