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

August 29, 2023 updated by: andrea belluzzi, MD phD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • U.O. Gastroenterologia - Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 weeks
Changes in circulating cytokines levels
Time Frame: Baseline and 12 weeks
Change from baseline in plasma levels of cytokines after 12 weeks of intervention.
Baseline and 12 weeks
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Collaborators

University of Bologna
Conserve Italia
GAT Foods

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2017

Primary Completion (Actual)

July 19, 2023

Study Completion (Estimated)

December 29, 2023

Study Registration Dates

First Submitted

December 19, 2016

First Submitted That Met QC Criteria

December 19, 2016

First Posted (Estimated)

December 21, 2016

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBSI14LHMB
  • SIR Programme no. RBSI14LHMB (Other Grant/Funding Number: MIUR Italian Ministry of Education, University and Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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