Oral Administration of AlequelTM for Patients With Inflammatory Bowel Disease (IBD)

Crohn's Disease Clinical Trial

Official title:

Phase 2 Clinical Trial for Oral Administration of Alequel for Patients With IBD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185183
• Other study ID #: YI2014-HMO-CTIL
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 28, 2014
• Last updated: September 21, 2014
• Start date: January 2008
• Est. completion date: January 2010

Study information

• Verified date: January 2008
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Oral administration of Alequel, a mixture of proteins derived from the patient's bowel will be tested in patients with inflammatory bowel disease.

Description:

Oral administration of Alequel prepared from patients biopsies will be tested in patients with inflammatory bowel disease to determine its anti inflammatory effect.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Crohn's disease

Exclusion Criteria:

• Immune suppression

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases

Intervention

Drug:
• Alequel
Alequel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Improved in Disease Activity		15 weeks	No