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

The Effect of Probiotics on Bowel Disease

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01078935

Enrollment

100

Registered

2010-03-02

Start date

2012-12-31

Completion date

Unknown

Last updated

2011-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Ulcerative Colitis

Keywords

Crohn's disease activity index, CDAI

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).

Interventions

DIETARY_SUPPLEMENTprobiotics

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_SUPPLEMENTplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* patients with ulcerative colitis and crohns' disease

Exclusion criteria

. * notable caveats are that arteries smaller than 2.5 mm

Design outcomes

Primary

Measure	Time frame
Truelove and Witts Classification of Ulcerative Colitis	2 years
Crohn's disease activity index (CDAI)	2 years

Contacts

Primary ContactArnon Blum, DR

ablum@poria.health.gov.il972466522688

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026