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

NCT ID: NCT01765998

Last Updated: 2013-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-02-28

Brief Summary

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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

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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.

Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Probiotic

Intervention Type DRUG

Clinical evaluation according to the Crohn's activity scale

placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Probiotic

Clinical evaluation according to the Crohn's activity scale

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Bio 25 powder in HPMC Capsule

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Baruch Padeh Medical Center, Poriya

OTHER_GOV

Sponsor Role lead

Responsible Party

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Arnon Blum

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arnon Blum, MD

Role: PRINCIPAL_INVESTIGATOR

Baruch Padeh Medical Center

Locations

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Baruch Padeh Medical Center

Tiberias, Lower Galilee, Israel

Site Status

Countries

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Israel

Other Identifiers

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18-2012.CTIL

Identifier Type: -

Identifier Source: org_study_id

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