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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 70 Years
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hillel Yaffe Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Baruch Ovadia, MD
Principal Investigator Affiliation Hillel Yaffe Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Not yet recruiting
Countries Israel

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Arms & Interventions


Active Comparator: Modulen Diet

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


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

Contact a Trial Team

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International Sites

Hillel Yaffe Medical Center, Hadera, Israel



Hillel Yaffe Medical Center

Hadera, , 38100

Site Contact

Baruch Ovadia, MD


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