Additive Modified Mediterranean Dietary Intervention Versus Modified Anti-inflammatory Dietary Intervention for Inflammatory Bowel Disease Remission
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Induction of disease remission (CD) by adding adjunct dietary interventions combined with pharmacotherapy.
研究概览
简要总结
- To compare adding dietary intervention based on MD to dietary intervention based on IBD-AID on induction of disease remission of IBD patients receiving pharmacotherapy.
- To compare patients' adherence to dietary intervention based on MD to dietary intervention based on IBD-AID, and the impact of adherence on induction of remission among patients with IBD receiving pharmacotherapy.
详细描述
Inflammatory bowel disease (IBD) is a chronic inflammatory disorder with two major types; ulcerative colitis (UC) and Crohn's disease (CD) . There is a growing incidence of IBD in the Arab world, with incidence rate of 2.33 per 100,000 persons per year for UC and 1.46 per 100,000 persons per year for CD.
Due to this increasing incidence, it is likely that IBD will become a major health problem in the future.
Pathogenesis of IBD is not fully understood yet, recent studies suggest that IBD is associated with a multifactorial process involving genetics, environmental factors, microbiota, and deregulation of the immune system.
Diet is one of the environmental factors involved in the onset and course of IBD. Accumulating evidence points to gut dysbiosis combined with aberrant immune response in genetically predisposed individuals; a process probably triggered and maintained by changes in environmental factors, including diet ; the exact interplay between these factors is still unknown.
Since the prevalence of IBD is highest in the Western world, affecting up to 0.5% of the general population in 2015, it is thought that the Western diet, high in fats and sugars and low in vegetables and fruits, contributes to the development of IBD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •• Diagnosis of IBD (according to clinical, endoscopic and histological criteria).
- •Receiving pharmacotherapy for IBD.
排除标准
- •Pediatric patients (less than 18 years old)
- •Pregnant or breastfeeding patients
- •Patients with concomitant alimentary tract disorders, such as malabsorption and celiac disease
- •Patients requiring specific dietary interventions, such as diabetes mellitus, heart failure, renal failure, nephrosis, and liver failure, and neoplastic disorders.
结局指标
主要结局
Induction of disease remission (CD) by adding adjunct dietary interventions combined with pharmacotherapy.
时间窗: 12 weeks
. For Crohn's disease patients, Modified Harvey Bradshaw Index will be used with score ≤ 5 indicate remission, =5-7mild disease ,8-16 moderate disease, ≥ 16 in severe disease.
Induction of disease remission by adding adjunct dietary interventions combined with pharmacotherapy.
时间窗: 12 weeks
by standard biochemical procedures, such as C-reactive protein (CRP).
Induction of disease remission (UC) by adding adjunct dietary interventions combined with pharmacotherapy.
时间窗: 12 weeks
For UC patients, Clinician based Simple Clinical Colitis Activity Index (SCCAI) categorize two types of patients: patients with inactive disease (SCCAI score \< 5) and patients with active disease (SCCAI score ≥ 5).
次要结局
- Adherence of IBD patients to adjunct dietary interventions, and its impact on induction of remission.(12 weeks)
研究者
Dina Khaled Mostafa Mohamed
Assistant lecturer of Tropical Medicine and Gastroenterology
Assiut University