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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04233463
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

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.

Condition or disease Intervention/treatment Phase
Crohn Disease Dietary Supplement: Modulen Drug: Budesonide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Active Comparator: Modulen Diet
Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet
Dietary Supplement: Modulen
Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet

Active Comparator: Budesonide Treatment
Crohn patients will be given Budesonide treatment
Drug: Budesonide
Standard treatment for mild Crohn Disease patients




Primary Outcome Measures :
  1. Efficacy of Modulen Diet [ Time Frame: 8 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04233463


Contacts
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Contact: Baruch Ovadia, MD 972-545767372 ovadiabaruch@gmail.com

Locations
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Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Contact: Baruch Ovadia, MD    972-545767372    ovadiabaruch@gmail.com   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
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Principal Investigator: Baruch Ovadia, MD Hillel Yaffe Medical Center
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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT04233463    
Other Study ID Numbers: 0128-18-HYMC
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists