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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2013 by The Baruch Padeh Medical Center, Poriya.
Recruitment status was Not yet recruiting

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

History of Changes

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:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

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 (Adult)
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


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 Intestinal Diseases Inflammatory Bowel Diseases Disease Progression Gastroenteritis	Gastrointestinal Diseases Digestive System Diseases Disease Attributes Pathologic Processes

ClinicalTrials.gov processed this record on September 27, 2016

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