A Single-center Open-label Study to Determine the Effect of Diet on Microbiome Signatures in Crohn's Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Maintenance of Symptomatic Remission, Without Worsening of Any Existing Disease Activity During Study Period
研究概览
简要总结
This protocol is designed to compare the effectiveness of a soy-based diet or identical diet without soy given to patients with Crohn's disease (CD) in remission, patients with active CD, or healthy controls. The assigned diet will be compared to participant 'baseline' (pre-diet) in terms of its ability to change the gut bacteria and fecal butyrate, an important short-chain fatty acid (SCFA) that limits bowel inflammation, a characteristic of this debilitating disease.
详细描述
The inflammatory bowel disease (IBD) subtype, Crohn's disease (CD) is a chronic and relapsing inflammatory disorder of the gastrointestinal tract. Although the precise etiology of IBD is not known, evidence suggests that environmental factors, including diet, contribute to its pathogenesis. A soy-based diet has been demonstrated to have numerous health benefits. This single-center open-label study will compare the effectiveness of a soy-based diet or an identical diet without soy to change the gut microbiota composition and fecal butyrate concentration to that of baseline (pre-diet) in patients with CD (remission or active disease) and healthy control subjects without CD. Participants will follow either a soy-based diet or an identical diet without soy to which they will be randomized for 7 days. No data collection or other study procedures will take place until the potential participant provides written informed consent to participate in the research study. The informed consent, screening, enrollment, and baseline data collection which make up visit 1 can occur on the same day or be completed across several days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •CD subjects: Documented diagnosis of Crohn's disease. Control subjects: no documented diagnosis of CD.
- •CD subjects: Harvey Bradshaw Index (HBI) score <4 ('CD remission'), or with HBI score >8 ('CD moderate disease')
- •Capable of providing consent to participate
- •Access to technology that permits the daily completion of study related activities
- •Able to receive and have an adult sign for food shipments delivered to a work or home environment.
- •Negative pregnancy test at screening visit in females of childbearing potential
- •Able to take oral nutrition and medication intake for 3 months prior to and at time of study enrolment.
- •'CD remission' subjects: No change in 'IBD related' medications within 8 weeks prior to normally scheduled appointment with treating gastroenterologist (pre-screening): biologics, immunosuppressants, corticosteroids.
排除标准
- •Short bowel syndrome.
- •Hospitalized patients
- •Body mass Index <19 kg/m or ≥
- •Known clinically significant liver/gallbladder/pancreatic disease/dysfunction
- •Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.
- •Uncontrolled Diabetes Type I type II
- •Known drug abuse.
- •Known parasitic disease of the digestive system. symptomatic intestinal stricture.
- •Presence of an ostomy.
- •Known concurrent malignancy.
- •Other conditions that would be a contraindication to and of the study diets (e.g. Soy, peanut, wheat, gluten allergy.) or preclude the participant from completing the study
- •Start of new 'IBD related' medications within 8 weeks prior to enrollment: biologics, immunosuppressants, corticosteroids.
- •Documented C difficile colitis within four weeks of screening
- •Well-founded doubt about the patient's cooperation.
- •Existing pregnancy or lactation.
- •Current participation in another diet intervention, simultaneous participation in another clinical trial, or participation in any other dietary intervention trial within the last 30 days.
- •History of <3 natural bowel movements per week.
- •Unable to access to technology that permits the daily completion of study related activities.
- •Currently consuming a soy-based diet
研究组 & 干预措施
Soy-based diet
Participants will be randomized to follow a soy-based diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
干预措施: Soy based diet (Other)
Regular diet
Participants will be randomized to follow a diet without soy for 7 days. The diet will be preceded by a 12-hr overnight fast.
干预措施: Non-soy based diet (Other)
结局指标
主要结局
Maintenance of Symptomatic Remission, Without Worsening of Any Existing Disease Activity During Study Period
时间窗: 7 days
The primary aim will measure the Crohn's Disease Activity Index (CDAI) at the enrollment and end of study visit. CDAI scores can range from 0 to \~600 (A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease). Herein, a cut-off value of \<150 was selected so that most patients below this threshold would be rated by physicians as 'very well'. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point \[i.e., value at 7 days (post) minus value at baseline/enrollment (pre)\].
Change in Fecal Myleoperoxidase (MPO) Activity
时间窗: 7 days
Change in fecal myleoperoxidase (MPO) activity at day 7 vs day 0.
次要结局
- Changes to Functional Composition of Gut Microbiota(measured after the 7-day diet intervention)
- Percentage of Subjects Who Continue Diet Following Completion of Study(6 months)
研究者
Abigail Basson
PostDoctoral Fellow
Case Western Reserve University