Clinical trial NCT03000101: Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Disease
Official title: New Insight and Knowledge on Anti-inflammatory Effectiveness of Dietary Phenolics (NIKE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Crohn's Disease
Ulcerative Colitis
Keywords: Biomarkers
Colitis
Colitis, Ulcerative
Colonic Diseases
Crohn Disease
Digestive System Diseases
Fruit
Fruit and Vegetable Juices
Gastroenteritis
Gastrointestinal Diseases
Humans
Hydrolysable Tannins
Inflammation
Inflammatory Bowel Disease
Intestinal Diseases
Punicaceae
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
Collaborators: name: University of Bologna
name: Conserve Italia
name: GAT Foods
First posted: 2016-12-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients with Ulcerative Colitis (diagnosed on the base of clinic, endoscopic, and histologic criteria) in clinical remission (SCCAI = 0) from at least three months and in stable therapy (without therapeutic modifications in the three previous months) with mesalazine, immunomodulators and/or biologics.
* Patients affected by Crohn's Disease, particularly involving sigmoid colon and rectum (diagnosed on the base of clinic, endoscopic, and histologic criteria) in clinical remission (CDAI \< 150) from at least three months and in stable therapy (without therapeutic modifications in the three previous months) with mesalazine A, immunomodulators and/or biologics.
* Fecal calprotectin at baseline ≥ 100 microg/g.
* Signed informed consent.

Exclusion Criteria:

* Patients affected by Ulcerative Colitis and Crohn's Disease with severe endoscopic disease activity (Ulcerative Colitis: Mayo Endoscopic Score = 3; Crohn's Disease: Simple Endoscopic Score SES-CD \> 15).
* Patients on steroid therapy in the two previous months.
* Patients in therapy with warfarin or other anticoagulants.
* Known or supposed hypersensitivity to fruit and/or juice of pomegranate.
* Women in fertile age which refuse to use contraceptives specified in the study (oral contraception, IUD) and breastfeed women.
* Diabetic patients and other patients with severe clinical conditions which the investigator consider to contraindicate patient participation at the study.
* Therapy modifications and/or assumption of experimental therapies within three months before the study inclusion.

Primary outcomes:
measure: Changes in fecal calprotectin
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Changes in plasma concentration of ellagitannin metabolites
timeFrame: Baseline and 12 weeks
measure: Changes in circulating cytokines levels
timeFrame: Baseline and 12 weeks
measure: Changes in circulating trimethylamine-N-oxide (TMAO) levels
timeFrame: Baseline and 12 weeks
measure: Changes in gene expression levels in peripheral blood mononuclear cells (PBMC)
timeFrame: Baseline and 12 weeks
measure: Changes in gene expression levels in intestinal biopsies
timeFrame: Baseline and 12 weeks
measure: Changes in urinary ellagitannin metabolite excretion
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: U.O. Gastroenterologia - Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi
Study officials:
affiliation: Department of Agri-Food Sciences and Technologies, University of Bologna
name: Francesca Danesi, PhD
role: STUDY_DIRECTOR
affiliation: Department of Medical and Surgical Sciences, University of Bologna
name: Luigi Ricciardiello, MD, Prof
role: PRINCIPAL_INVESTIGATOR
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