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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Arnon Blum, The Baruch Padeh Medical Center, Poriya.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Arnon Blum, The Baruch Padeh Medical Center, Poriya Identifier:
First received: January 6, 2013
Last updated: January 10, 2013
Last verified: January 2013
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.

Condition Intervention Phase
Crohn's Disease
Drug: Probiotic
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation (Crohn's Disease) and Markers of Inflammation

Resource links provided by NLM:

Further study details as provided by Arnon Blum, The Baruch Padeh Medical Center, Poriya:

Primary Outcome Measures:
  • endothelial stem cells [ Time Frame: one year ]
    to study the ability to create endothelial progenitor stem cells following probiotic management compared to placebo group

Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01765998

Baruch Padeh Medical Center
Tiberias, Lower galilee, Israel, 15208
Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya
Principal Investigator: Arnon Blum, MD Baruch Padeh Medical Center
  More Information

Responsible Party: Arnon Blum, Doctor, The Baruch Padeh Medical Center, Poriya Identifier: NCT01765998     History of Changes
Other Study ID Numbers: 18-2012.CTIL
Study First Received: January 6, 2013
Last Updated: January 10, 2013

Keywords provided by Arnon Blum, The Baruch Padeh Medical Center, Poriya:
Crohn's disease, endothelial progenitor cells, probiotic

Additional relevant MeSH terms:
Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Disease Progression
Gastrointestinal Diseases
Digestive System Diseases
Disease Attributes
Pathologic Processes processed this record on May 25, 2017