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

September 21, 2014 updated by: Hadassah Medical Organization

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Crohn's disease

Exclusion Criteria:

  • Immune suppression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AlequelTM
Drug: Alequel
Alequel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Improved in Disease Activity
Time Frame: 15 weeks
15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Study Director: Yaron Ilan, M.D., Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

July 6, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

October 1, 2014

Last Update Submitted That Met QC Criteria

September 21, 2014

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YI2014-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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