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

NCT01078935 | Unknown Phase 4

• 1 other identifier: Prob-bl.CTIL
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Crohn's Disease; Ulcerative Colitis

Keywords

Crohn's disease activity index; CDAI

Outcome Measures

Primary Outcomes (2)

• Truelove and Witts Classification of Ulcerative Colitis

  2 years

• Crohn's disease activity index (CDAI)

  2 years

Interventions

probiotics DIETARY_SUPPLEMENT

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.

placebo DIETARY_SUPPLEMENT

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 Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with ulcerative colitis and crohns' disease

You may not qualify if:

• notable caveats are that arteries smaller than 2.5 mm

Sponsors & Collaborators

• The Baruch Padeh Medical Center, Poriya: lead
• Ministry of Health, Israel: collaborator

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Arnon Blum, DR

CONTACT

972466522688; ablum@poria.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: December 1, 2012
• Primary Completion: April 1, 2014
• Last Updated: August 11, 2011

Record last verified: 2010-03