NCT03000101Completed
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)
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 19 Dec 2016
- Start date
- 19 Jan 2017
- Primary completion date
- 19 Jul 2023
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT03000101
What you commit to
- Study type: Interventional
- Participants enrolled: 18
- From 19 Jan 2017 to the primary completion date, 19 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients on steroid therapy in the two previous months.
- Patients in therapy with warfarin or other anticoagulants.
- Therapy modifications and/or assumption of experimental therapies within three months before the study inclusion.
Other illness
- 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).
- Known or supposed hypersensitivity to fruit and/or juice of pomegranate.
- Diabetic patients and other patients with severe clinical conditions which the investigator consider to contraindicate patient participation at the study.
Age
- Women in fertile age which refuse to use contraceptives specified in the study (oral contraception, IUD) and breastfeed women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| U.O. Gastroenterologia - Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.