Effect of Pomegranate Juice on Gut Inflammation, Quality of Life and the Gut Microbiome in Patients With Ulcerative Colitis: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- simple clinical colitis activity index (SCCAI)
研究概览
简要总结
The purpose of this study is to determine whether consumption of 237 ml of pomegranate juice daily for 8 weeks will:
- lower inflammation (in the gut as well as generally in the body) and improve your overall quality of life
- affect the microbes living in the gut (gut microbiota)
详细描述
the study is aimed at evaluating the effects of pomegranate juice (PomJ) on: 1) gut inflammation (fecal calprotectin and Simple Clinical Colitis Activity Index) and quality of life; 2) circulating inflammatory markers (e.g., hs-CRP, IL-6, IL-10, TNF-a, IL-1b, IL-8, LBP, LPS) and markers of oxidative stress (blood and urine malondialdehyde (MDA)) and 3) gut microbiota composition and functionality (urinary and circulating urolithin metabolites, fecal SCFAs/BAs, blood LBP and LPS, etc.). We will perform a randomized, controlled, 16-week trial to generate preliminary evidence on the effects of PomJ consumption in patients with mild-to-moderate UC. Participants will be randomly assigned to one of two groups: intervention group and delayed start group. The study will involve 2 phases, each lasting for 8 weeks. During Phase 1, the intervention group will consume 237 ml of PomJ daily, while the delayed start group will follow their habitual diet. Data generated from the delayed start group during Phase 1 will serve as the control for the study. During Phase 2, the intervention group will stop consuming PomJ and switch to consuming their habitual diet, while the delayed start group will consume 237 ml of PomJ daily for 8 weeks. Data generated from the intervention group during Phase 2 will serve as a follow-up to explore whether the effects of PomJ consumption persist after consumption is stopped (this will be an exploratory outcome).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Adults ≥ 18 yo
- •Following a low-polyphenol and fiber diet (< 3 servings of fruits/vegetables per day)
- •Mild-to-moderate UC at the time of screening (2 ≤ partial Mayo scores ≤ 5)
- •Supportive evidence of active inflammation (hsCRP >1 mg/L, fecal calprotectin >50 µg/g stool, or abnormal lower endoscopy) in individuals with biopsy-proven UC
- •Patients on 5-aminosalicylates must be on a stable dose for ≥ 4 weeks prior to screening
- •Patients on treatment with immunosuppressive therapy (e.g., azathioprine/6-mercaptopurine, methotrexate) must be on stable dose for 8 weeks prior to baseline visit
- •At the time of baseline visit, patients may be on no more than 20 mg/day of prednisone and 9 mg/day of budesonide MMX
- •Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.
排除标准
- •• Non-English speaker
- •Vegetarian/vegan
- •Known pomegranate allergy
- •Documented chronic disease besides UC, including diabetes, renal or liver diseases, metabolic syndrome, active cancer, MI or stroke, history of gastric bypass
- •Patients with CD, indeterminate/severe to fulminant colitis
- •History of colectomy or colonic dysplasia
- •Presence of ileal pouch or ostomy
- •Evidence of active bacterial or viral gastroenteritis as indicated by positive stool studies for ova & parasites, Clostridium difficile, and stool culture
- •Recent hospitalizations (within 2 weeks of screening) for UC requiring IV steroids
- •Presence of the following labs indicative of severe colitis: a. Hemoglobin < 8.0 g/dl b. Albumin < 3.0 g/dl
- •Recent systemic antibiotics use (within 3 months of screening) or active use of anti-diarrheal medications
- •Taking supplements known to affect metabolism or gut microbiota composition (probiotics, fiber, etc.), unless willing to stop for the study duration
- •Use of Total Parenteral Nutrition (TPN)
- •Use of cyclosporine, tacrolimus, or thalidomide within 2 months prior to screening
- •Taking exogenous hormones (e.g., hormone replacement therapy)
- •Recent weight fluctuations (>10% in the last 6 months)
- •Smoker or living with a smoker
- •Use of >20 g of alcohol per day
- •Unable or unwilling to comply with the study protocol (including unwillingness to avoid watermelon and other lycopene-rich foods for the whole duration of the study)
- •Unable to provide consent
研究组 & 干预措施
Intervention
Participants in this arm will be consuming 237 ml of pomegranate juice for the first 8 weeks of the study and their habitual diet without pomegranate juice for the second 8 weeks
干预措施: pomegranate juice -> habitual diet (Other)
Delayed start
Participants in this arm will consume their habitual diet for the first 8 weeks of the study and drink 237 ml of pomegranate juice for the second 8 weeks
干预措施: habitual diet -> pomegranate juice (Other)
结局指标
主要结局
simple clinical colitis activity index (SCCAI)
时间窗: At baseline, 8 weeks and 16 weeks
Simple Clinical Colitis Activity Index (SCCAI) includes questions about bowel frequency, urgency of defecation, etc. Measured by the number of points/scores.
Fecal calprotectin
时间窗: At baseline, 8 weeks and 16 weeks
To evaluate effects of PomJ on gut inflammation in patients with mild-to-moderate UC. The primary outcome will be levels of fecal calprotectin (objective measure). Fecal calprotectin levels will be assessed via a commercially available ELISA kit in mcg/g.
次要结局
- Biomarkers of inflammation and oxidative stress(At baseline, weeks 8 and 16)
- Biomarkers of aging and oxidative stress(At baseline, week 8 and week 16)
- Biomarkers of inflammation and oxidative stress(At baseline, week 8 and week 16)
- Biomarkers of inflammation and oxidative stress(At baseline, week 8 and 16)
- Biomarkers of inflammation and oxidative stress(At Baseline, weeks 8 and 16)
研究者
Zhaoping Li
Principal Investigator
University of California, Los Angeles