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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03000101
Recruitment Status : Active, not recruiting
First Posted : December 21, 2016
Last Update Posted : January 13, 2020
Sponsor:
Collaborators:
University of Bologna
Conserve Italia
GAT Foods
Information provided by (Responsible Party):
andrea belluzzi, MD phD, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Ulcerative Colitis Other: 100% pomegranate juice Other: placebo beverage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: New Insight and Knowledge on Anti-inflammatory Effectiveness of Dietary Phenolics (NIKE)
Actual Study Start Date : January 19, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pomegranate juice
The pomegranate juice is 100% pomegranate juice, not from concentrate.
Other: 100% pomegranate juice
125 mL of 100% pomegranate juice twice daily for 12 weeks

Placebo Comparator: Placebo beverage
The placebo beverage consists in water added with sugar and citric acid.
Other: placebo beverage
125 mL of placebo beverage twice daily for 12 weeks




Primary Outcome Measures :
  1. Changes in fecal calprotectin [ Time Frame: 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 Outcome Measures :
  1. Changes in plasma concentration of ellagitannin metabolites [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in plasma concentration of ellagitannin metabolites after 12 weeks of intervention.

  2. Changes in circulating cytokines levels [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in plasma levels of cytokines after 12 weeks of intervention.

  3. Changes in circulating trimethylamine-N-oxide (TMAO) levels [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in plasma levels of TMAO after 12 weeks of intervention.

  4. Changes in gene expression levels in peripheral blood mononuclear cells (PBMC) [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in expression levels of selected genes in PBMC by qPCR after 12 weeks of intervention.

  5. Changes in gene expression levels in intestinal biopsies [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in expression levels of selected genes in intestinal biopsies by qPCR after 12 weeks of intervention.

  6. Changes in urinary ellagitannin metabolite excretion [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in urinary ellagitannin metabolite excretion after 12 weeks of intervention.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000101


Locations
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Italy
U.O. Gastroenterologia - Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi
Bologna, Italy, 40138
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
University of Bologna
Conserve Italia
GAT Foods
Investigators
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Study Director: Francesca Danesi, PhD Department of Agri-Food Sciences and Technologies, University of Bologna
Principal Investigator: Luigi Ricciardiello, MD, Prof Department of Medical and Surgical Sciences, University of Bologna
Publications of Results:
Other Publications:

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Responsible Party: andrea belluzzi, MD phD, Andrea Belluzzi, MD PhD, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT03000101    
Other Study ID Numbers: RBSI14LHMB
SIR Programme no. RBSI14LHMB ( Other Grant/Funding Number: MIUR - Italian Ministry of Education, University and Research )
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by andrea belluzzi, MD phD, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
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
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Ulcer
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases