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

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ClinicalTrials.gov Identifier: NCT01765998
Recruitment Status : Unknown
Verified January 2013 by Arnon Blum, The Baruch Padeh Medical Center, Poriya.
Recruitment status was:  Not yet recruiting
First Posted : January 11, 2013
Last Update Posted : January 11, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Crohn's Disease Drug: Probiotic Drug: Placebo Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : February 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765998


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

Responsible Party: Arnon Blum, Doctor, The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier: NCT01765998     History of Changes
Other Study ID Numbers: 18-2012.CTIL
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: January 11, 2013
Last Verified: January 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
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Disease Attributes
Pathologic Processes