search
Back to results

The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation

Primary Purpose

Crohn's Disease, Ulcerative Colitis

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

About this trial

This is an interventional prevention trial for Crohn's Disease focused on measuring Crohn's disease activity index, CDAI

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with ulcerative colitis and crohns' disease

Exclusion Criteria:.

  • notable caveats are that arteries smaller than 2.5 mm

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Truelove and Witts Classification of Ulcerative Colitis
    Crohn's disease activity index (CDAI)

    Secondary Outcome Measures

    Full Information

    First Posted
    March 1, 2010
    Last Updated
    August 10, 2011
    Sponsor
    The Baruch Padeh Medical Center, Poriya
    Collaborators
    Ministry of Health, Israel
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01078935
    Brief Title
    The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation
    Official Title
    The Effect of Probiotics on Bowel Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2012 (undefined)
    Primary Completion Date
    April 2014 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    The Baruch Padeh Medical Center, Poriya
    Collaborators
    Ministry of Health, Israel

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Fifty patients will get probiotics (109 bacteria [L. acidophilus, B. bifidum, S. thermophilus, L. rhamnosus, L. casei] in 2 capsules) and half will get placebo (2 capsules that look the same like the probiotic capsules and will contain microcrystalline cellulose, artificial brown color, magnesium strearate, and silica dioxide). The patients and the staff will be blinded to the identity of the study medications. Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed. Each individual will be studied for changes in biochemical inflammatory and immunological markers and changes in flow medicated diameter that will be measured by the brachial artery method (that is evaluating endothelial function). Every patient will be evaluated for his/her ability to produce endothelial progenitor stem cells (EPCs).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crohn's Disease, Ulcerative Colitis
    Keywords
    Crohn's disease activity index, CDAI

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    probiotics
    Intervention Description
    Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo
    Intervention Description
    Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed.
    Primary Outcome Measure Information:
    Title
    Truelove and Witts Classification of Ulcerative Colitis
    Time Frame
    2 years
    Title
    Crohn's disease activity index (CDAI)
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with ulcerative colitis and crohns' disease Exclusion Criteria:. notable caveats are that arteries smaller than 2.5 mm
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arnon Blum, DR
    Phone
    972466522688
    Email
    ablum@poria.health.gov.il

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation

    We'll reach out to this number within 24 hrs