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Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Disease — POME2016  

Ulcerative Colitis Clinical Trial

Official title:
New Insight and Knowledge on Anti-inflammatory Effectiveness of Dietary Phenolics (NIKE)

Clinical Trial Summary

The aim of this research is to study the effects of a pomegranate juice on calprotectin levels in patients suffering of inflammatory bowel disease (IBD) in clinical remission. Fecal calprotectin levels, surrogate marker of mucosal inflammation, will be measured from baseline to 12 weeks later (end of intervention). Systemic and mucosal changes of biochemical and molecular inflammatory response markers will be also assessed.

Clinical Trial Description

The main purpose of the intervention trial is to assess the possible effect of pomegranate juice consumption on reducing fecal calprotectin (FC) levels in volunteers suffering from IBD with a high risk of clinical relapse. In detail, the objectives of this intervention are as follows: (i) assessing the changes in FC levels in the two groups (active treatment, control) from baseline to 12 weeks later (primary outcome); (ii) investigating the systemic and mucosal modifications of selected biochemical and molecular inflammatory response markers in the two groups after 12 weeks of the intervention compared with baseline (secondary outcomes); (iii) evaluating circulating and urinary ellagitannin-derived metabolites from regular pomegranate juice consumption in the two groups before and after the intervention. The detailed study protocol is published in the Trials journal. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03000101
Study type Interventional
Source IRCCS Azienda Ospedaliero-Universitaria di Bologna
Contact
Status Active, not recruiting
Phase N/A
Start date January 19, 2017
Completion date December 29, 2023
View Details
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