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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01765998
Date of registration: 06/01/2013
Prospective Registration: Yes
Primary sponsor: The Baruch Padeh Medical Center, Poriya
Public title: The Effect of Probiotics on Exacerbation of Inflammatory Bowel Disease Exacerbation (Crohn's Disease)
Scientific title: The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation (Crohn's Disease) and Markers of Inflammation
Date of first enrolment: February 2013
Target sample size: 60
Recruitment status: Not yet recruiting
URL:  http://clinicaltrials.gov/show/NCT01765998
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science  
Phase:  Phase 4
Countries of recruitment
Israel
Contacts
Name:     Arnon Blum, MD
Address: 
Telephone:
Email:
Affiliation:  Baruch Padeh Medical Center
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: Probiotic
Drug: Placebo
Primary Outcome(s)
endothelial stem cells [Time Frame: one year]
Secondary Outcome(s)
Secondary ID(s)
18-2012.CTIL
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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