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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 15, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJanuary 18, 2020
January 1, 2020
1 year
January 15, 2020
January 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Modulen Diet
ACTIVE COMPARATORCrohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet
Budesonide Treatment
ACTIVE COMPARATORCrohn patients will be given Budesonide treatment
Interventions
Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet
Eligibility Criteria
You may qualify if:
- Newly diagnosed Crohn's Disease
- Mild to moderate severity
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hillel Yaffe Medical Center
Hadera, 38100, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Baruch Ovadia, MD
Hillel Yaffe Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2020
First Posted
January 18, 2020
Study Start
January 1, 2020
Primary Completion
January 1, 2021
Study Completion
June 1, 2021
Last Updated
January 18, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share