search
Back to results

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

Primary Purpose

Crohn's Disease

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
The Baruch Padeh Medical Center, Poriya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Crohn's Disease focused on measuring Crohn's disease, endothelial progenitor cells, probiotic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baruch Padeh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

placebo

Arm Description

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.

This will be the comparison group to the experimantal group that recives Probiotic.

Outcomes

Primary Outcome Measures

endothelial stem cells
to study the ability to create endothelial progenitor stem cells following probiotic management compared to placebo group

Secondary Outcome Measures

Full Information

First Posted
January 6, 2013
Last Updated
January 10, 2013
Sponsor
The Baruch Padeh Medical Center, Poriya
search

1. Study Identification

Unique Protocol Identification Number
NCT01765998
Brief Title
The Effect of Probiotics on Exacerbation of Inflammatory Bowel Disease Exacerbation (Crohn's Disease)
Official Title
The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation (Crohn's Disease) and Markers of Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Baruch Padeh Medical Center, Poriya

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's disease, endothelial progenitor cells, probiotic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
This will be the comparison group to the experimantal group that recives Probiotic.
Intervention Type
Drug
Intervention Name(s)
Probiotic
Other Intervention Name(s)
Bio 25, powder in HPMC Capsule
Intervention Description
Clinical evaluation according to the Crohn's activity scale
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
endothelial stem cells
Description
to study the ability to create endothelial progenitor stem cells following probiotic management compared to placebo group
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnon Blum, MD
Organizational Affiliation
Baruch Padeh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baruch Padeh Medical Center
City
Tiberias
State/Province
Lower galilee
ZIP/Postal Code
15208
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs