Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Disease
NCT ID: NCT03000101
Last Updated: 2023-08-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
18 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-01-19
Study Completion Date
2023-12-29
Brief Summary
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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.
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Detailed Description
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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.
The detailed study protocol is published in the Trials journal.
Conditions
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Crohn's Disease
Ulcerative Colitis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Pomegranate juice
The pomegranate juice is 100% pomegranate juice, not from concentrate.
Group Type
EXPERIMENTAL
100% pomegranate juice
Intervention Type
OTHER
125 mL of 100% pomegranate juice twice daily for 12 weeks
Placebo beverage
The placebo beverage consists in water added with sugar and citric acid.
Group Type
PLACEBO_COMPARATOR
placebo beverage
Intervention Type
OTHER
125 mL of placebo beverage twice daily for 12 weeks
Interventions
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100% pomegranate juice
125 mL of 100% pomegranate juice twice daily for 12 weeks
Intervention Type
OTHER
placebo beverage
125 mL of placebo beverage twice daily for 12 weeks
Intervention Type
OTHER
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Bologna
OTHER
Sponsor Role
collaborator
Conserve Italia
UNKNOWN
Sponsor Role
collaborator
GAT Foods
OTHER
Sponsor Role
collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Sponsor Role
lead
Responsible Party
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andrea belluzzi, MD phD
Andrea Belluzzi, MD PhD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Francesca Danesi, PhD
Role: STUDY_DIRECTOR
Department of Agri-Food Sciences and Technologies, University of Bologna
Luigi Ricciardiello, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Department of Medical and Surgical Sciences, University of Bologna
Locations
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U.O. Gastroenterologia - Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi
Bologna, , Italy
Site Status
Countries
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Italy
References
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Biasi F, Astegiano M, Maina M, Leonarduzzi G, Poli G. Polyphenol supplementation as a complementary medicinal approach to treating inflammatory bowel disease. Curr Med Chem. 2011;18(31):4851-65. doi: 10.2174/092986711797535263.
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Gimenez-Bastida JA, Larrosa M, Gonzalez-Sarrias A, Tomas-Barberan F, Espin JC, Garcia-Conesa MT. Intestinal ellagitannin metabolites ameliorate cytokine-induced inflammation and associated molecular markers in human colon fibroblasts. J Agric Food Chem. 2012 Sep 12;60(36):8866-76. doi: 10.1021/jf300290f. Epub 2012 Apr 16.
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Rosillo MA, Sanchez-Hidalgo M, Cardeno A, Aparicio-Soto M, Sanchez-Fidalgo S, Villegas I, de la Lastra CA. Dietary supplementation of an ellagic acid-enriched pomegranate extract attenuates chronic colonic inflammation in rats. Pharmacol Res. 2012 Sep;66(3):235-42. doi: 10.1016/j.phrs.2012.05.006. Epub 2012 Jun 4.
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Schoepfer AM, Trummler M, Seeholzer P, Seibold-Schmid B, Seibold F. Discriminating IBD from IBS: comparison of the test performance of fecal markers, blood leukocytes, CRP, and IBD antibodies. Inflamm Bowel Dis. 2008 Jan;14(1):32-9. doi: 10.1002/ibd.20275.
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BACKGROUND
Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med. 1987 Dec 24;317(26):1625-9. doi: 10.1056/NEJM198712243172603.
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BACKGROUND
Walmsley RS, Ayres RC, Pounder RE, Allan RN. A simple clinical colitis activity index. Gut. 1998 Jul;43(1):29-32. doi: 10.1136/gut.43.1.29.
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Wilson A, Teft WA, Morse BL, Choi YH, Woolsey S, DeGorter MK, Hegele RA, Tirona RG, Kim RB. Trimethylamine-N-oxide: A Novel Biomarker for the Identification of Inflammatory Bowel Disease. Dig Dis Sci. 2015 Dec;60(12):3620-30. doi: 10.1007/s10620-015-3797-3. Epub 2015 Jul 10.
Reference Type
BACKGROUND
Scaioli E, Belluzzi A, Ricciardiello L, Del Rio D, Rotondo E, Mena P, Derlindati E, Danesi F. Pomegranate juice to reduce fecal calprotectin levels in inflammatory bowel disease patients with a high risk of clinical relapse: Study protocol for a randomized controlled trial. Trials. 2019 Jun 6;20(1):327. doi: 10.1186/s13063-019-3321-8.
Reference Type
RESULT
Minato I, Mena P, Ricciardiello L, Scaioli E, Belluzzi A, Rotondo E, Derlindati E, Montanini B, Michelini C, Tosi N, Agullo Garcia V, Picone G, Mengucci C, Dobani S, Salamanca P, Rosi A, Dall'Asta M, Bresciani L, Curti C, Spisni E, Dei Cas A, Bordoni A, Tomas-Barberan FA, Ferguson LR, Del Rio D, Danesi F. Evidence for a Modulatory Effect of a 12-Week Pomegranate Juice Intervention on the Transcriptional Response in Inflammatory Bowel Disease Patients Reducing Fecal Calprotectin Levels: Findings From a Proof-of-Principle Study. Mol Nutr Food Res. 2025 Aug;69(15):e70067. doi: 10.1002/mnfr.70067. Epub 2025 Apr 21.
Reference Type
DERIVED
Other Identifiers
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SIR Programme no. RBSI14LHMB
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
RBSI14LHMB
Identifier Type: -
Identifier Source: org_study_id
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