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临床试验/NCT04552158
NCT04552158Unknown不适用

Nutritional Assessment and Impact of the Mediterranean Diet on Patients With Inflammatory Bowel Disease

Yasmin Ashraf Mahmoud Osman0 个研究点目标入组 50 人开始时间: 2021年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
Assessment of nutritional status among patients with inflammatory bowel disease using the anthropometric measures

研究概览

简要总结

  1. Assessment of nutritional status among patients with inflammatory bowel disease using different nutritional assessment tools.
  2. Assessment of correlation between nutritional status and disease severity.
  3. Assessment of the impact of the Mediterranean diet on the nutritional status of the patients after 3 months.

详细描述

Inflammatory bowel diseases (IBD) comprise a variety of disorders that result from the continuous activation of the immunoinflammatory cascade, whose etiology has not been defined in some cases. Classical IBD include Crohn's disease (CD), ulcerative colitis (UC), and indeterminate colitis. These diseases are chronic and are characterized by alternating periods of recurrence and remission.

The European Society of Clinical Nutrition and Metabolism (ESPEN) defined malnutrition as a state resulting from lack of uptake or intake of nutrition leading to altered body composition (decreased fat-free mass and body cell mass), resulting in diminished physical and mental function and impaired clinical outcome from disease.

The prevalence of Malnutrition in patients with inflammatory bowel disease (IBD) is very high. it presents in up to 70% of patients with active disease and up to 38% in patients with remission.

Several factors contribute to the malnutrition in IBD including insufficient nutrient intake as a consequence of impaired appetite (anorexia, stomachache), short bowel syndrome, impaired nutrient absorption (diarrhea, villus atrophy, bowel resection, intestinal flora overgrowth), increased nutrient losses (bleeding, fistulae), and food-drug interaction.

Malnutrition in IBD has been associated with several adverse clinical outcomes. IBD patients with nutritional deficiencies may present with higher mortality rate, length of stay in the hospital, infectious rate, and even thromboembolic events than those without nutritional deficiencies. Furthermore, undernutrition in patients with postoperative conditions has been associated with increased complications such as anastomotic leakage and breakdown, infection including sepsis and pneumonia, prolonged hospitalization, and increased mortality.

研究设计

研究类型
Interventional
分配方式
Non 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 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients with inflammatory bowel disease between 18 to 55 years

排除标准

  • presence of other diseases that affect the nutritional status of the patients like diabetes mellitus, liver cirrhosis, chronic kidney disease, and malignancy

结局指标

主要结局

Assessment of nutritional status among patients with inflammatory bowel disease using the anthropometric measures

时间窗: Two time points: Change in the anthropometric parameters at patient presentation and after 3 months of medical management only

triceps skin fold thickness (TST) in mm, mid arm circumference(MAC) in cm and mid arm muscle circumference in cm (MAMC) MAMC (cm) = MAC(cm) - { 0.314 X TST(mm) }.

Assessment of nutritional status among patients with inflammatory bowel disease using body weight

时间窗: Two time points: Change in body weight at patient presentation and after 3 months of medical management only

current body weight in kilograms will be measured

Assessment of nutritional status among patients with inflammatory bowel disease using body mass index (BMI)

时间窗: Two time points: Change in BMI at patient presentation and after 3 months of medical management only

current body weight in kilograms and height in meters will be measured BMI is calculated in kg/m2

Assessment of nutritional status among patients with inflammatory bowel disease using prognostic nutritional index (PNI)

时间窗: Two time points: Change in PNI score at patient presentation and after 3 months of medical management only

prognostic nutritional index (PNI) which is score derived from total lymphocytic count (TLC)and serum albumin (PNI = albumin g/dl x 10 + TLC/µL x 0.005)

Assessment of nutritional status among patients with inflammatory bowel disease using controlling nutritional status(CONUT)

时间窗: Two time points: Change in CONUT score at patient presentation and after 3 months of medical management only

controlling nutritional status (CONUT) is also a score derived from total lymphocytic count, serum albumin and blood cholesterol level

次要结局

  • Assessment of the impact of Mediterranean diet on the nutritional status for patients who received the Mediterranean diet after 3 months(after 3 months of medical and Mediterranean diet management)

研究者

发起方
Yasmin Ashraf Mahmoud Osman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yasmin Ashraf Mahmoud Osman

assistant lecturer

Assiut University

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