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

Not Applicable

Active, not recruiting

• Conditions: Ulcerative Colitis; Crohn's Disease
• Interventions: Other: placebo beverage; Other: 100% pomegranate juice

• Registration Number: NCT03000101
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-21
• Study Start: 2017-01-19
• Primary Completion: 2023-07-19
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30
• Study Completion: 2023-12-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo beverage	placebo beverage	The placebo beverage consists in water added with sugar and citric acid.
Pomegranate juice	100% pomegranate juice	The pomegranate juice is 100% pomegranate juice, not from concentrate.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.
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 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.

Trial Locations

Locations (1)

U.O. Gastroenterologia - Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi; 🇮🇹 Bologna, Italy