World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04233463
Date of registration: 15/01/2020
Prospective Registration: Yes
Primary sponsor: Hillel Yaffe Medical Center
Public 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
Scientific 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
Date of first enrolment: January 2020
Target sample size: 50
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT04233463
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Israel
Contacts
Name:     Baruch Ovadia, MD
Address: 
Telephone: 972-545767372
Email: ovadiabaruch@gmail.com
Affiliation: 
Name:     Baruch Ovadia, MD
Address: 
Telephone: 972-545767372
Email: ovadiabaruch@gmail.com
Affiliation: 
Name:     Baruch Ovadia, MD
Address: 
Telephone:
Email:
Affiliation:  Hillel Yaffe Medical Center
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Intervention(s)
Dietary Supplement: Modulen
Drug: Budesonide
Primary Outcome(s)
Efficacy of Modulen Diet [Time Frame: 8 weeks]
Secondary Outcome(s)
Secondary ID(s)
0128-18-HYMC
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history