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

Ulcerative Colitis Clinical Trial

— POME2016  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03000101
• Other study ID #: RBSI14LHMB
• Secondary ID: SIR Programme no
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 19, 2017
• Est. completion date: December 29, 2023

Study information

• Verified date: August 2023
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: December 29, 2023
• Est. primary completion date: July 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Intervention

Other:
• 100% pomegranate juice
125 mL of 100% pomegranate juice twice daily for 12 weeks
• placebo beverage
125 mL of placebo beverage twice daily for 12 weeks

Locations

Country	Name	City	State
Italy	U.O. Gastroenterologia - Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi	Bologna

Sponsors (4)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna	Conserve Italia, GAT Foods, University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in fecal calprotectin	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	Changes in plasma concentration of ellagitannin metabolites	Change from baseline in plasma concentration of ellagitannin metabolites after 12 weeks of intervention.	Baseline and 12 weeks
Secondary	Changes in circulating cytokines levels	Change from baseline in plasma levels of cytokines after 12 weeks of intervention.	Baseline and 12 weeks
Secondary	Changes in circulating trimethylamine-N-oxide (TMAO) levels	Change from baseline in plasma levels of TMAO after 12 weeks of intervention.	Baseline and 12 weeks
Secondary	Changes in gene expression levels in peripheral blood mononuclear cells (PBMC)	Change from baseline in expression levels of selected genes in PBMC by qPCR after 12 weeks of intervention.	Baseline and 12 weeks
Secondary	Changes in gene expression levels in intestinal biopsies	Change from baseline in expression levels of selected genes in intestinal biopsies by qPCR after 12 weeks of intervention.	Baseline and 12 weeks
Secondary	Changes in urinary ellagitannin metabolite excretion	Change from baseline in urinary ellagitannin metabolite excretion after 12 weeks of intervention.	Baseline and 12 weeks