Crohn's DiseasePOME2016NCT03000101
Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Disease
A study testing 100% pomegranate juice in people with Crohn's Disease and Ulcerative Colitis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- What is being tested?
- 100% pomegranate juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jan 2017to 29 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
U.O. Gastroenterologia - Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi
Bologna, 40138
About this study
Official title: 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.
Read the 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.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Being tested
- 100% pomegranate juice, placebo beverage
- Keywords
- Biomarkers, Colitis, Colitis, Ulcerative, Colonic Diseases, Crohn Disease, Digestive System Diseases, Fruit, Fruit and Vegetable Juices, Gastroenteritis, Gastrointestinal Diseases, Humans, Hydrolysable Tannins, Inflammation, Inflammatory Bowel Disease, Intestinal Diseases, Punicaceae
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Colitis, Colonic Diseases, Digestive System Diseases, Gastroenteritis, Gastrointestinal Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% pomegranate juiceOther
125 mL of 100% pomegranate juice twice daily for 12 weeks
placebo beverageOther
125 mL of placebo beverage twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pomegranate juice | Experimental | The pomegranate juice is 100% pomegranate juice, not from concentrate. Receives: Other: 100% pomegranate juice |
| Placebo beverage | Placebo comparator | The placebo beverage consists in water added with sugar and citric acid. Receives: Other: placebo beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Secondary outcomes (6)
Changes in plasma concentration of ellagitannin metabolites
Change from baseline in plasma concentration of ellagitannin metabolites after 12 weeks of intervention.
Measured: Baseline and 12 weeks
Changes in circulating cytokines levels
Change from baseline in plasma levels of cytokines after 12 weeks of intervention.
Measured: Baseline and 12 weeks
Changes in circulating trimethylamine-N-oxide (TMAO) levels
Change from baseline in plasma levels of TMAO after 12 weeks of intervention.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
Changes in urinary ellagitannin metabolite excretion
Change from baseline in urinary ellagitannin metabolite excretion after 12 weeks of intervention.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start19 Jan 2017
- Primary completion19 Jul 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna, Conserve Italia, GAT Foods
- Responsible party
- Principal investigator, andrea belluzzi, MD phD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Francesca Danesi, PhD, Study director, Department of Agri-Food Sciences and Technologies, University of BolognaLuigi Ricciardiello, MD, Prof, Principal investigator, Department of Medical and Surgical Sciences, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000101
- Sponsor's protocol ID
- RBSI14LHMB
- Other IDs
- SIR Programme no. RBSI14LHMB
- Acronym
- POME2016
- Status last verified
- Jul 2026
- First submitted
- 19 Dec 2016
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Best WR, Becktel JM, Singleton JW. Rederived values of the eight coefficients of the Crohn's Disease Activity Index (CDAI). Gastroenterology. 1979 Oct;77(4 Pt 2):843-6.
PubMed 467941Biasi 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.
PubMed 21919842Costa F, Mumolo MG, Ceccarelli L, Bellini M, Romano MR, Sterpi C, Ricchiuti A, Marchi S, Bottai M. Calprotectin is a stronger predictive marker of relapse in ulcerative colitis than in Crohn's disease. Gut. 2005 Mar;54(3):364-8. doi: 10.1136/gut.2004.043406.
PubMed 15710984D'Inca R, Dal Pont E, Di Leo V, Ferronato A, Fries W, Vettorato MG, Martines D, Sturniolo GC. Calprotectin and lactoferrin in the assessment of intestinal inflammation and organic disease. Int J Colorectal Dis. 2007 Apr;22(4):429-37. doi: 10.1007/s00384-006-0159-9. Epub 2006 Jul 13.
PubMed 16838143D'Amore S, Vacca M, Graziano G, D'Orazio A, Cariello M, Martelli N, Di Tullio G, Salvia R, Grandaliano G, Belfiore A, Pellegrini F, Palasciano G, Moschetta A. Nuclear receptors expression chart in peripheral blood mononuclear cells identifies patients with Metabolic Syndrome. Biochim Biophys Acta. 2013 Dec;1832(12):2289-301. doi: 10.1016/j.bbadis.2013.09.006. Epub 2013 Sep 21.
PubMed 24060638Daperno M, D'Haens G, Van Assche G, Baert F, Bulois P, Maunoury V, Sostegni R, Rocca R, Pera A, Gevers A, Mary JY, Colombel JF, Rutgeerts P. Development and validation of a new, simplified endoscopic activity score for Crohn's disease: the SES-CD. Gastrointest Endosc. 2004 Oct;60(4):505-12. doi: 10.1016/s0016-5107(04)01878-4.
PubMed 15472670D'Haens G, Ferrante M, Vermeire S, Baert F, Noman M, Moortgat L, Geens P, Iwens D, Aerden I, Van Assche G, Van Olmen G, Rutgeerts P. Fecal calprotectin is a surrogate marker for endoscopic lesions in inflammatory bowel disease. Inflamm Bowel Dis. 2012 Dec;18(12):2218-24. doi: 10.1002/ibd.22917. Epub 2012 Feb 16.
PubMed 22344983Espin JC, Gonzalez-Barrio R, Cerda B, Lopez-Bote C, Rey AI, Tomas-Barberan FA. Iberian pig as a model to clarify obscure points in the bioavailability and metabolism of ellagitannins in humans. J Agric Food Chem. 2007 Dec 12;55(25):10476-85. doi: 10.1021/jf0723864. Epub 2007 Nov 9.
PubMed 17990850Foell D, Frosch M, Sorg C, Roth J. Phagocyte-specific calcium-binding S100 proteins as clinical laboratory markers of inflammation. Clin Chim Acta. 2004 Jun;344(1-2):37-51. doi: 10.1016/j.cccn.2004.02.023.
PubMed 15149869Geboes K, Riddell R, Ost A, Jensfelt B, Persson T, Lofberg R. A reproducible grading scale for histological assessment of inflammation in ulcerative colitis. Gut. 2000 Sep;47(3):404-9. doi: 10.1136/gut.47.3.404.
PubMed 10940279Gimenez-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.
PubMed 22463485Larrosa M, Gonzalez-Sarrias A, Yanez-Gascon MJ, Selma MV, Azorin-Ortuno M, Toti S, Tomas-Barberan F, Dolara P, Espin JC. Anti-inflammatory properties of a pomegranate extract and its metabolite urolithin-A in a colitis rat model and the effect of colon inflammation on phenolic metabolism. J Nutr Biochem. 2010 Aug;21(8):717-25. doi: 10.1016/j.jnutbio.2009.04.012. Epub 2009 Jul 18.
PubMed 19616930Marin M, Maria Giner R, Rios JL, Recio MC. Intestinal anti-inflammatory activity of ellagic acid in the acute and chronic dextrane sulfate sodium models of mice colitis. J Ethnopharmacol. 2013 Dec 12;150(3):925-34. doi: 10.1016/j.jep.2013.09.030. Epub 2013 Oct 17.
PubMed 24140585Martin DA, Bolling BW. A review of the efficacy of dietary polyphenols in experimental models of inflammatory bowel diseases. Food Funct. 2015 Jun;6(6):1773-86. doi: 10.1039/c5fo00202h.
PubMed 25986932Mesko B, Poliska S, Szegedi A, Szekanecz Z, Palatka K, Papp M, Nagy L. Peripheral blood gene expression patterns discriminate among chronic inflammatory diseases and healthy controls and identify novel targets. BMC Med Genomics. 2010 May 5;3:15. doi: 10.1186/1755-8794-3-15.
PubMed 20444268
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Insight and Knowledge on Anti-inflammatory Effectiveness of Dietary Phenolics (NIKE)
- ClinicalTrials.gov ID
- NCT03000101
- Acronym / sponsor ID
- POME2016 / RBSI14LHMB
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Biomarkers, Colitis, Colitis, Ulcerative, Colonic Diseases, Crohn Disease, Digestive System Diseases, Fruit, Fruit and Vegetable Juices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- University of Bologna, Conserve Italia, GAT Foods
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pomegranate juice | Experimental | Other: 100% pomegranate juiceThe pomegranate juice is 100% pomegranate juice, not from concentrate. |
| Placebo beverage | Placebo comparator | Other: placebo beverageThe placebo beverage consists in water added with sugar and citric acid. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 100% pomegranate juice125 mL of 100% pomegranate juice twice daily for 12 weeks | Other | Pomegranate juice |
| placebo beverage125 mL of placebo beverage twice daily for 12 weeks | Other | Placebo beverage |
Primary outcome
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.
6 secondary outcomes
Changes in plasma concentration of ellagitannin metabolites
Time frame: Baseline and 12 weeks
Changes in circulating cytokines levels
Time frame: Baseline and 12 weeks
Changes in circulating trimethylamine-N-oxide (TMAO) levels
Time frame: Baseline and 12 weeks
Changes in gene expression levels in peripheral blood mononuclear cells (PBMC)
Time frame: Baseline and 12 weeks
Changes in gene expression levels in intestinal biopsies
Time frame: Baseline and 12 weeks
Changes in urinary ellagitannin metabolite excretion
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Background: PubMed 467941Best WR, Becktel JM, Singleton JW. Rederived values of the eight coefficients of the Crohn's Disease Activity Index (CDAI). Gastroenterology. 1979 Oct;77(4 Pt 2):843-6.
- Background: PubMed 21919842Biasi 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.
- Background: PubMed 15710984Costa F, Mumolo MG, Ceccarelli L, Bellini M, Romano MR, Sterpi C, Ricchiuti A, Marchi S, Bottai M. Calprotectin is a stronger predictive marker of relapse in ulcerative colitis than in Crohn's disease. Gut. 2005 Mar;54(3):364-8. doi: 10.1136/gut.2004.043406.
- Background: PubMed 16838143D'Inca R, Dal Pont E, Di Leo V, Ferronato A, Fries W, Vettorato MG, Martines D, Sturniolo GC. Calprotectin and lactoferrin in the assessment of intestinal inflammation and organic disease. Int J Colorectal Dis. 2007 Apr;22(4):429-37. doi: 10.1007/s00384-006-0159-9. Epub 2006 Jul 13.
- Background: PubMed 24060638D'Amore S, Vacca M, Graziano G, D'Orazio A, Cariello M, Martelli N, Di Tullio G, Salvia R, Grandaliano G, Belfiore A, Pellegrini F, Palasciano G, Moschetta A. Nuclear receptors expression chart in peripheral blood mononuclear cells identifies patients with Metabolic Syndrome. Biochim Biophys Acta. 2013 Dec;1832(12):2289-301. doi: 10.1016/j.bbadis.2013.09.006. Epub 2013 Sep 21.
- Background: PubMed 15472670Daperno M, D'Haens G, Van Assche G, Baert F, Bulois P, Maunoury V, Sostegni R, Rocca R, Pera A, Gevers A, Mary JY, Colombel JF, Rutgeerts P. Development and validation of a new, simplified endoscopic activity score for Crohn's disease: the SES-CD. Gastrointest Endosc. 2004 Oct;60(4):505-12. doi: 10.1016/s0016-5107(04)01878-4.
- Background: PubMed 22344983D'Haens G, Ferrante M, Vermeire S, Baert F, Noman M, Moortgat L, Geens P, Iwens D, Aerden I, Van Assche G, Van Olmen G, Rutgeerts P. Fecal calprotectin is a surrogate marker for endoscopic lesions in inflammatory bowel disease. Inflamm Bowel Dis. 2012 Dec;18(12):2218-24. doi: 10.1002/ibd.22917. Epub 2012 Feb 16.
- Background: PubMed 17990850Espin JC, Gonzalez-Barrio R, Cerda B, Lopez-Bote C, Rey AI, Tomas-Barberan FA. Iberian pig as a model to clarify obscure points in the bioavailability and metabolism of ellagitannins in humans. J Agric Food Chem. 2007 Dec 12;55(25):10476-85. doi: 10.1021/jf0723864. Epub 2007 Nov 9.
- Background: PubMed 15149869Foell D, Frosch M, Sorg C, Roth J. Phagocyte-specific calcium-binding S100 proteins as clinical laboratory markers of inflammation. Clin Chim Acta. 2004 Jun;344(1-2):37-51. doi: 10.1016/j.cccn.2004.02.023.
- Background: PubMed 10940279Geboes K, Riddell R, Ost A, Jensfelt B, Persson T, Lofberg R. A reproducible grading scale for histological assessment of inflammation in ulcerative colitis. Gut. 2000 Sep;47(3):404-9. doi: 10.1136/gut.47.3.404.
- Background: PubMed 22463485Gimenez-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.
- Background: PubMed 19616930Larrosa M, Gonzalez-Sarrias A, Yanez-Gascon MJ, Selma MV, Azorin-Ortuno M, Toti S, Tomas-Barberan F, Dolara P, Espin JC. Anti-inflammatory properties of a pomegranate extract and its metabolite urolithin-A in a colitis rat model and the effect of colon inflammation on phenolic metabolism. J Nutr Biochem. 2010 Aug;21(8):717-25. doi: 10.1016/j.jnutbio.2009.04.012. Epub 2009 Jul 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesca Danesi, PhD study director
Department of Agri-Food Sciences and Technologies, University of Bologna
Luigi Ricciardiello, MD, Prof principal investigator
Department of Medical and Surgical Sciences, University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100% pomegranate juice in people with Crohn's Disease and Ulcerative Colitis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fecal calprotectin (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03000101, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.