Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by The Baruch Padeh Medical Center, Poriya
Sponsor:
Information provided by (Responsible Party):
Arnon Blum, The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier:
NCT01765998
First received: January 6, 2013
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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 (Subject, Caregiver, 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 The Baruch Padeh Medical Center, Poriya:

Primary Outcome Measures:
  • endothelial stem cells [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 6, 2013
Last Updated: January 10, 2013
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014