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Status unknownNCT04233463Updated Jan 18, 2020

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

An interventional study of Modulen and Budesonide in Crohn Disease, sponsored by Hillel Yaffe Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-01-18.

Sponsored by Hillel Yaffe Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Crohn Disease

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03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 50 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Hillel Yaffe Medical Center is the lead sponsor of 301 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Newly diagnosed Crohn's Disease
  • Mild to moderate severity

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • Active comparator
    Budesonide Treatment

    Crohn patients will be given Budesonide treatment

    Drug: Budesonide

Interventions

  • Dietary supplementModulen

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

  • DrugBudesonide

    Standard treatment for mild Crohn Disease patients

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What researchers measure

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.

    Time frame: 8 weeks

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Study locations

1 site
  • Hillel Yaffe Medical Center
    Hadera, 38100, Israel
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04233463
Lead sponsor
Hillel Yaffe Medical Center
Responsible party
Sponsor
First posted
Jan 18, 2020
Start date
Jan 2020 (estimated)
Primary completion
Jan 2021 (estimated)
Completion
Jun 2021 (estimated)
Last update
Jan 18, 2020

Study contacts

Baruch Ovadia, MD
Contact
ovadiabaruch@gmail.com
972-545767372
Baruch Ovadia, MD
principal investigator · Hillel Yaffe Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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