The Effect of Grapes in Inflammatory Bowel Disease
概览
- 阶段
- 不适用
- 干预措施
- Freeze dried grape powder
- 疾病 / 适应症
- Crohn Disease
- 发起方
- Case Western Reserve University
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- fecal microbiota composition
- 状态
- 已完成
- 最后更新
- 上个月
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.
研究者
入排标准
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.
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
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)