Crohn's Disease, Ulcerative Colitis
Conditions
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
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.
Interventions
OTHER100% pomegranate juice
125 mL of 100% pomegranate juice twice daily for 12 weeks
OTHERplacebo beverage
125 mL of placebo beverage twice daily for 12 weeks
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
University of Bologna
Conserve Italia
GAT Foods
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in fecal calprotectin | Baseline and 12 weeks | Change from baseline in fecal neutrophil-derived protein calprotectin, surrogate marker of mucosal improvement, after 12 weeks of consumption of experimental or placebo beverage, in subjects affected by IBD in clinical remission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in plasma concentration of ellagitannin metabolites | Baseline and 12 weeks | Change from baseline in plasma concentration of ellagitannin metabolites after 12 weeks of intervention. |
| Changes in circulating cytokines levels | Baseline and 12 weeks | Change from baseline in plasma levels of cytokines after 12 weeks of intervention. |
| Changes in circulating trimethylamine-N-oxide (TMAO) levels | Baseline and 12 weeks | Change from baseline in plasma levels of TMAO after 12 weeks of intervention. |
| Changes in gene expression levels in peripheral blood mononuclear cells (PBMC) | Baseline and 12 weeks | Change from baseline in expression levels of selected genes in PBMC by qPCR after 12 weeks of intervention. |
| Changes in gene expression levels in intestinal biopsies | Baseline and 12 weeks | Change from baseline in expression levels of selected genes in intestinal biopsies by qPCR after 12 weeks of intervention. |
| Changes in urinary ellagitannin metabolite excretion | Baseline and 12 weeks | Change from baseline in urinary ellagitannin metabolite excretion after 12 weeks of intervention. |
Countries
Italy
Contacts
STUDY_DIRECTORFrancesca Danesi, PhD
Department of Agri-Food Sciences and Technologies, University of Bologna
PRINCIPAL_INVESTIGATORLuigi Ricciardiello, MD, Prof
Department of Medical and Surgical Sciences, University of Bologna
Outcome results
None listed