Trials / Unknown
UnknownNCT04233463
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 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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Hillel Yaffe Medical Center · Other Government
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-01-01
- Primary completion
- 2021-01-01
- Completion
- 2021-06-01
- First posted
- 2020-01-18
- Last updated
- 2020-01-18
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT04233463. Inclusion in this directory is not an endorsement.