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

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

Sponsors

Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Collaborator: University of Bologna
Conserve Italia
GAT Foods

Source IRCCS Azienda Ospedaliero-Universitaria di Bologna
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.

Overall Status Active, not recruiting
Start Date 2017-01-19
Completion Date 2023-07-01
Primary Completion Date 2022-09-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in fecal calprotectin Baseline and 12 weeks
Secondary Outcome
Measure Time Frame
Changes in plasma concentration of ellagitannin metabolites Baseline and 12 weeks
Changes in circulating cytokines levels Baseline and 12 weeks
Changes in circulating trimethylamine-N-oxide (TMAO) levels Baseline and 12 weeks
Changes in gene expression levels in peripheral blood mononuclear cells (PBMC) Baseline and 12 weeks
Changes in gene expression levels in intestinal biopsies Baseline and 12 weeks
Changes in urinary ellagitannin metabolite excretion Baseline and 12 weeks
Enrollment 18
Condition
Intervention

Intervention Type: Other

Intervention Name: 100% pomegranate juice

Description: 125 mL of 100% pomegranate juice twice daily for 12 weeks

Arm Group Label: Pomegranate juice

Intervention Type: Other

Intervention Name: placebo beverage

Description: 125 mL of placebo beverage twice daily for 12 weeks

Arm Group Label: Placebo beverage

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: U.O. Gastroenterologia - Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi
Location Countries

Italy

Verification Date

2022-02-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigator Full Name: andrea belluzzi, MD phD

Investigator Title: Andrea Belluzzi, MD PhD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Pomegranate juice

Type: Experimental

Description: The pomegranate juice is 100% pomegranate juice, not from concentrate.

Label: Placebo beverage

Type: Placebo Comparator

Description: The placebo beverage consists in water added with sugar and citric acid.

Acronym POME2016
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Basic Science

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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 [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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