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

Crohn's Disease Clinical Trial

Official title:

The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation (Crohn's Disease) and Markers of Inflammation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01765998
• Other study ID #: 18-2012.CTIL
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 6, 2013
• Last updated: January 10, 2013
• Start date: February 2013
• Est. completion date: February 2014

Study information

• Verified date: January 2013
• Source: The Baruch Padeh Medical Center, Poriya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases

Intervention

Drug:
• Probiotic
Clinical evaluation according to the Crohn's activity scale
• Placebo

Locations

Country	Name	City	State
Israel	Baruch Padeh Medical Center	Tiberias	Lower galilee

Sponsors (1)

Lead Sponsor	Collaborator
The Baruch Padeh Medical Center, Poriya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelial stem cells	to study the ability to create endothelial progenitor stem cells following probiotic management compared to placebo group	one year	No