The Effect of Probiotics on Exacerbation of Inflammatory Bowel Disease Exacerbation (Crohn's Disease)

January 10, 2013 updated by: Arnon Blum, The Baruch Padeh Medical Center, Poriya

The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation (Crohn's Disease) and Markers of Inflammation

Inflammatory Bowel Disease (IBD) is an immune mediated chronic intestinal condition. It includes ulcerative colitis (UC) and Crohn's disease(CD). probiotics have been shown to be effective in varried clinical conditions ranging fron infantile diarrhea, necrotizing enterocolitis,helicobacter pylori infections, etc.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a prospective study that will enroll 50 patients with Crohn's disease.Each patient will get the study medication for 6 weeks and will be evaluated twice- before enrollment and after 6 weeks of treatment.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Lower galilee
      • Tiberias, Lower galilee, Israel, 15208
        • Baruch Padeh Medical Center

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 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with Crohns' disease who are stable or have mild acute exacerbations that do not necessitate treatment with systemic corticosteroids

Exclusion Criteria:

  • pregnant women, under 18 years or over 60 years,
  • patients with known ulcerative colitis,
  • patients with any cancer,
  • patients with heart failure

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Probiotic
To study the effect of probiotic on the ability to build endothelial progenitor stem cells and to study clinical recovery of patients with Crohn's Disease.
Drug: Probiotic
Clinical evaluation according to the Crohn's activity scale
Other Names:
  • Bio 25
  • powder in HPMC Capsule
PLACEBO_COMPARATOR: placebo
This will be the comparison group to the experimantal group that recives Probiotic.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endothelial stem cells
Time Frame: one year
to study the ability to create endothelial progenitor stem cells following probiotic management compared to placebo group
one year

Collaborators and Investigators

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

Sponsor

The Baruch Padeh Medical Center, Poriya

Investigators

  • Principal Investigator: Arnon Blum, MD, Baruch Padeh Medical Center

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

February 1, 2013

Primary Completion (ANTICIPATED)

February 1, 2014

Study Completion (ANTICIPATED)

February 1, 2014

Study Registration Dates

First Submitted

January 6, 2013

First Submitted That Met QC Criteria

January 10, 2013

First Posted (ESTIMATE)

January 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2013

Last Update Submitted That Met QC Criteria

January 10, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-2012.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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