ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01078935
Recruitment Status : Unknown
Verified March 2010 by The Baruch Padeh Medical Center, Poriya.
Recruitment status was:  Not yet recruiting
First Posted : March 2, 2010
Last Update Posted : August 11, 2011
Sponsor:
Collaborator:
Ministry of Health, Israel
Information provided by:
The Baruch Padeh Medical Center, Poriya

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).


Condition or disease Intervention/treatment Phase
Crohn's Disease Ulcerative Colitis Dietary Supplement: probiotics Dietary Supplement: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Probiotics on Bowel Disease
Study Start Date : December 2012
Estimated Primary Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease


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.


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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

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

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 Posted: March 2, 2010    Key Record Dates
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