Adaptation of the Mediterranean Diet Pattern to the Exclusion Diet for Crohn's Disease: Assessment of Efficacy and Tolerability in Pediatric and Adult Patients. Non-profit, Multicenter, Randomized, Controlled Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Adherence rate to the Med-CDED diet and comparison to the original CDED both in pediatric and adult cohort
研究概览
简要总结
The proposed study aims to assess the efficacy and tolerability of adapting the CDED to the Mediterranean diet pattern, without compromising its key principles, namely the exclusion of ultra-processed foods with potential pro-inflammatory effects on the intestines. The decision to modify the CDED according to the characteristics of the Mediterranean diet pattern and to evaluate the potential of this modified version of the exclusion diet for Crohn's disease in terms of efficacy and tolerability are the main objectives of this study.
These objectives are driven not only by scientific evidence regarding the anti-inflammatory potential and protective role against chronic-degenerative diseases demonstrated by the Mediterranean diet but also to allow for greater adherence to Italian dietary traditions and improve compliance with the dietary regimen.
Furthermore, to date, there are no comprehensive multi-omic investigations integrating dietary data with microbiome, metabolome, and transcriptome profiles that can demonstrate the effect of the CDED at "omic" levels. A very recent study on pediatric patients shows interesting results regarding differential profiles of fecal metabolites after administration of CDE or NEE in different weeks of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a stable diagnosis of Crohn's disease according to the criteria of the ECCO/ESPGHAN guidelines.
- •Patients with a new diagnosis of the disease or with a disease diagnosed no more than three years ago, receiving stable pharmacological therapy for at least 2 months with immunomodulators (thiopurines, methotrexate, azathioprine) or biologic drugs who have experienced a disease relapse and require reinduction of remission.
- •Mild to moderate disease activity assessed by the wPCDAI score between 12.5-57.5 in the pediatric population and a Harvey-Bradshaw Index ranging from 5 to 16 for the adult population.
- •Biochemical evidence of active intestinal inflammation at enrollment, assessed by inflammatory markers such as C-reactive protein (CRP) levels ≥ 0.5 mg/dl or fecal calprotectin ≥ 150 mg/g.
- •Ability to provide biological samples (stool and blood samples).
排除标准
- •Monogenic disease;
- •Disease with fibrostenotic or penetrating phenotype;
- •Complex perianal fistulizing disease not completely in remission;
- •Patients with ileostomy or who have undergone intestinal resection or colectomy;
- •Patients currently undergoing other nutritional therapy (e.g., exclusive enteral nutrition) or who have undergone it in the last month;
- •Patients not on stable therapy with immunomodulators or biologic drugs or who started therapy with thiopurines less than 4 weeks before enrollment, or methotrexate less than 8 weeks before enrollment;
- •Patients with recent use of systemic steroids in the four weeks before enrollment or recent initiation or dose adjustment phase of therapy with immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate) or biologic drugs;
- •Pregnancy;
- •Vegan or vegetarian patients;
- •Celiac disease.
研究组 & 干预措施
Med-CDED
The Mediterranean Crohn's Disease Exclusion Diet (Med-CDED) is the exclusion diet (CDED) adapted to the Mediterranean diet pattern. The Med-CDED consists of 2 phases in dietary therapy and a maintenance phase: the first phase lasting 8 weeks, the second phase lasting 16 weeks, and the maintenance phase, which for the purposes of the study will last 28 weeks.
干预措施: Mediterranean Crohn's Disease Exclusion Diet (Med-CDED) (Dietary Supplement)
CDED
The original Crohn's disease exclusion diet, used as a comparator, is widely employed among first-line treatments in clinical practice for inducing remission in pediatric patients with Crohn's disease
干预措施: Crohn's disease exclusion diet (CDED) (Dietary Supplement)
结局指标
主要结局
Adherence rate to the Med-CDED diet and comparison to the original CDED both in pediatric and adult cohort
时间窗: Anytime during the study
Adherence rate will be assessed by adherence questionnaire score or by considering the number of patients who refuse the diet
Clinical remission rate in adult patients at the end of phase I of diet
时间窗: 8 weeks
Clinical remission will be assessed by HBI \< 5 points
Clinical response to the first phase of diet
时间窗: 8 weeks
reduction of 12.5 points in the wPCDAI score.
Clinical remission rate
时间窗: 8 weeks
wPCDAI score must be \<12.5 points after the first phase of diet
次要结局
- Assessment of the trascriptome profiles at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort(52 weeks)
- Assessment of clinical remission rate at the end of Phase II of the Med-CDED diet and comparision with the original CDED both in pediatric and adult cohort(24 weeks)
- Endoscopic response rate obtained at 6 months both in pediatric and adult cohort(0 and 26 weeks)
- Assessment of the metabolome profiles at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort(52 weeks)
- Ability to maintain a healthy and balanced diet and patient satisfaction with the treatment both in pediatric and adult cohortreceived(Anytime during the study)
- Assessment of the reduction or normalization of inflammation markers both in pediatric and adult cohort(8 weeks)
- Assessment of clinical remission rate at the end of Phase III of the Med-CDED diet and comparision with the original CDED both in pediatric and adult cohort(52 weeks)
- Transmural response of the thickness of the intestinal loops both in pediatric and adult cohort(0, 8, 24, 38 and 52 weeks)
- Assessment of the modification of the intestinal microbiota composition (trough alpha and beta diversity) at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort(52 weeks)
研究者
Paolo Lionetti
Principal Investigator
Meyer Children's Hospital IRCCS