Preventing IBD Onset in Individuals at Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Reduction in fecal calprotectin (FC) levels over the 8 week Tasty & Healthy dietary intervention, reflecting improvement in intestinal inflammatory activity.
研究概览
简要总结
The goal of this study is to explore in a cross over randomized controlled trial, the ability of the Tasty&Healthy dietary intervention (NCT04239248) to alter the parameters associated with future risk of developing Chron's disease (CD) using First Degree Relatives of patients with Crohn's disease, including subjects identified in the Genetic Environmental Microbiome (GEM) Study as having a high-risk score. Specifically, the investigators aim to determine if the Tasty&Healthy dietary intervention can decrease the overall GEM Risk Score (GRS) and/or to alter the individual biological parameters that contribute to this score. The investigators hypothesize that the Tasty&Healthy dietary approach will alter the risk of CD as reflected by a decrease in the GRS.
详细描述
Several important factors associated with CD onset have already been identified in the GEM analyses, such as elevated faecal calprotectin(FC),altered gut permeability, proteomics, anti-microbial serology, and microbiome composition. These parameters are combined into the GEM Risk Score (GRS).
The first-line therapy in children with CD, according to ECCO/ESPGHAN guidelines, is exclusive enteral nutrition (EEN), meaning 8-12 weeks of exclusive liquid formula. Nutritional therapy may alter intestinal inflammation by several mechanisms, including modulation of the microbiome and an effect on intestinal permeability, both factors assessed in the GEM cohort. EEN is safe and effective, but it is challenging to implement.
Several diets, based on solid foods, have been proposed as alternatives to EEN in an attempt to increase feasibility, three of which have the most data.
Specific carbohydrate diet (SCD) restricts carbohydrates and processed foods and has been long used with variable reported effectiveness.
The CD-TREAT diet induced a positive change to the microbiome, children with active CD entered clinical remission with decreased inflammatory markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 6 Years 至 38 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically healthy subjects (i.e. lack of symptoms that may suggest IBD) who are First degree relatives of someone with CD with a high faecal calprotectin (FC)>70μg/g or subjects who have a risk factor for example elevated GRS. Where available LMR will also be assessed to identify subjects ranked as top 100 at risk of CD.
- •Younger than 39 years of age, in order to maximize future risk of developing CD.
- •No overt ulcerations (other than aphthous ulcerations) in the ileum or colon. Some degree of inflammation may be seen in these high-risk subjects with increased risk parameters and this does not necessarily prompt the diagnosis of CD. Moreover, in this proof of concept study we would like to have those with the highest risk (hence some degree of initial inflammation) but without macroscopic inflammation that clearly is associated with the diagnosis of CD. Patency capsule and VCE procedure will be performed if the subjects calprotectin levels are >70μg/g.
排除标准
- •Ulcerative colitis (UC) or IBD-unclassified (IBDU) diagnosis
- •The use of antibiotics in the preceding month
- •Prior intestinal resection
- •Pregnancy (and up until six months after giving birth)
- •Celiac disease or Diabetes
- •Weight loss or weight gain by more than 20% body weight in the last 3 months
- •Extraintestinal manifestations (Arthritis/arthralgia, iritis/uveitis, skin/mouth lesions, peri-anal disease, Other fistula).
- •Underweight (children <3th BMI percentile, adult above the age of 18 years: BMI<18.5 kg/m2).
研究组 & 干预措施
Tasty&Healthy
Tasty&Healthy intervention: subjects will receive dietary advice to exclude pro-inflammatory dietary components
干预措施: Tasty&Healthy (Other)
Habitual diet
Habitual diet: subjects will continue their habitual diet.
干预措施: Habitual diet (Other)
结局指标
主要结局
Reduction in fecal calprotectin (FC) levels over the 8 week Tasty & Healthy dietary intervention, reflecting improvement in intestinal inflammatory activity.
时间窗: 8 weeks of Tasty&Healthy diet.
Fecal calprotectin (FC) is a validated, sensitive marker of intestinal inflammation and reflects short term biological changes expected from the Tasty \& Healthy intervention. For this reason, the primary endpoint is a reduction in FC over the 8 weeks of the intervention.
次要结局
- Microbiome risk score (MRS) Change in one standard deviation.(8 weeks of Tasty&Healthy diet.)
- Change in Serum Metabolomics pre and post-intervention(8 weeks of Tasty&Healthy diet.)
- Lactulose-Mannitol Ratio (LMR) Change in one standard deviation.(8 weeks of Tasty&Healthy diet.)
- Change in Serum Proteomics pre and post-intervention(8 weeks of Tasty&Healthy diet.)
- Adherence with the interventions, including assessment of faecal gluten.(8 weeks of Tasty&Healthy diet.)
- Ability to maintain a balanced diet as measured by food diaries.(8 weeks of Tasty&Healthy diet.)
- Satisfaction with the treatment received, as assessed by the Satisfaction with Food-Related Life (SFRL) questionnaire.(8 weeks of Tasty&Healthy diet.)
- Change in routine blood biomarkers over the course of the 8 week intervention(8 weeks of Tasty&Healthy intervention)
研究者
Dr Dan Turner
Head of The Juliet Keidan Institute of Pediatric Gastroenterology & Nutrition
Shaare Zedek Medical Center