New Insight and Knowledge on Anti-inflammatory Effectiveness of Dietary Phenolics (NIKE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Changes in fecal calprotectin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Pomegranate juice
The pomegranate juice is 100% pomegranate juice, not from concentrate.
干预措施: 100% pomegranate juice (Other)
Placebo beverage
The placebo beverage consists in water added with sugar and citric acid.
干预措施: placebo beverage (Other)
结局指标
主要结局
Changes in fecal calprotectin
时间窗: 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.
次要结局
- Changes in circulating cytokines levels(Baseline and 12 weeks)
- Changes in circulating trimethylamine-N-oxide (TMAO) levels(Baseline and 12 weeks)
- Changes in gene expression levels in intestinal biopsies(Baseline and 12 weeks)
- Changes in urinary ellagitannin metabolite excretion(Baseline and 12 weeks)
- Changes in plasma concentration of ellagitannin metabolites(Baseline and 12 weeks)
- Changes in gene expression levels in peripheral blood mononuclear cells (PBMC)(Baseline and 12 weeks)
研究者
andrea belluzzi, MD phD
Andrea Belluzzi, MD PhD
IRCCS Azienda Ospedaliero-Universitaria di Bologna