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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by The Baruch Padeh Medical Center, Poriya.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01078935
First Posted: March 2, 2010
Last Update Posted: August 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, Israel
Information provided by:
The Baruch Padeh Medical Center, Poriya
  Purpose

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).


Condition Intervention Phase
Crohn's Disease Ulcerative Colitis Dietary Supplement: probiotics Dietary Supplement: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Probiotics on Bowel Disease

Resource links provided by NLM:


Further study details as provided by The Baruch Padeh Medical Center, Poriya:

Primary Outcome Measures:
  • Truelove and Witts Classification of Ulcerative Colitis [ Time Frame: 2 years ]
  • Crohn's disease activity index (CDAI) [ Time Frame: 2 years ]

Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: probiotics
    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.
    Dietary Supplement: placebo
    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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with ulcerative colitis and crohns' disease

Exclusion Criteria:.

  • notable caveats are that arteries smaller than 2.5 mm
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078935


Contacts
Contact: Arnon Blum, DR 972466522688 ablum@poria.health.gov.il

Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya
Ministry of Health, Israel
  More Information

Responsible Party: Arnon Blum, The baruch pade medical center, Poriya
ClinicalTrials.gov Identifier: NCT01078935     History of Changes
Other Study ID Numbers: Prob-bl.CTIL
First Submitted: March 1, 2010
First Posted: March 2, 2010
Last Update Posted: August 11, 2011
Last Verified: March 2010

Keywords provided by The Baruch Padeh Medical Center, Poriya:
Crohn's disease activity index
CDAI

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases