The Effect of Grapes in Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- fecal microbiota composition
研究概览
简要总结
The overall objective of this pilot intervention study is to determine the impact of grape powder (46g/day freeze dried whole grape powder provided by the California Table Grape Commission) on the gut microbiotacomposition in adult patients with the IBD subtype Crohn's disease (CD).
详细描述
This protocol is designed to investigate the effect of grape powder consumption in Inflammatory Bowel Disease (IBD), in particular how grape powder consumption (provided as 46g/day grape powder; equivalent to 1.5 cups fresh grapes) alters the gut microbiota (GM) composition in humans with IBD. The investigators will focus on studying IBD patients affected with CD as a proof of principle that could be tested later in other IBD subtype (ulcerative colitis or others specific surgical conditions).
The overall objective of this pilot intervention study is to determine the impact of grape powder (46g/day freeze dried whole grape powder provided by the California Table Grape Commission) on the GM composition in adult patients with the IBD subtype Crohn's disease (CD).
An 28 day pilot study in adult CD patients at the Digestive Health Institutes (DHI) of University Hospitals Cleveland Medical Center (UHCMC). table
Participation in this study will last for a maximum of 28 days and will consist of two phases. Phase I (baseline period - 7 days) where all grapes and berries will be removed from the diet, and Phase II (intervention period - 21 days) where participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily. The dose of 46g/day of grape powder is equivalent to 1.5 cups of grapes. Participants will be asked to avoid consumption of all other grapes/berries during phase II. The investigators will compare the before and after changes in gut microbiota composition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of Crohns disease. CD outpatients in remission
- •Harvey Bradshaw-index in remission (<6 score)
- •Capable of providing consent to participate.
- •Able to complete daily surveys and take oral nutrition
- •Able to record daily meal intake
排除标准
- •Short bowel syndrome.
- •Hospitalized patients.
- •Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.
- •Known drug abuse.
- •Known parasitic disease of the digestive system.
- •Symptomatic intestinal stricture.
- •Presence of an ostomy.
- •Other conditions that would be a contraindication to consumption of the study diets or preclude the participant from completing the study.
- •Well-founded doubt about the patients cooperation.
- •Existing pregnancy or lactation.
- •History of <1 natural bowel movements per day.
- •Unable to access to technology that permits the daily completion of study related activities.
- •Change in IBD medication within past 4 weeks.
- •Body mass Index <16 kg/m or ≥
- •Documented C.difficile colitis within four weeks of screening.
- •Known berry or grape allergy
- •No probiotic or antibiotic use for the previous 14 days
研究组 & 干预措施
Freeze-dried Grape powder intervention
participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily for 21 days.
干预措施: Freeze dried grape powder (Dietary Supplement)
结局指标
主要结局
fecal microbiota composition
时间窗: baseline (pre-intervention), immediately after the intervention
16S microbiome
次要结局
- fecal calprotectin(baseline (pre-intervention), immediately after the intervention)
- C-reactive protein (CRP)(baseline (pre-intervention), immediately after the intervention)
- fecal myleoperoxidase (MPO)(baseline (pre-intervention), immediately after the intervention)