Preoperative Nutrition for Crohn's Disease Patients
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Changes in adherence to therapy
研究概览
简要总结
The investigator hypothesizes that compliance to Exclusive enteral nutrition (EEN) will be high among patients on an operation for their bowel disease, compared to the compliance rate seen in the general Crohn's Disease (CD) population.
Also,the investigator hypothesizes that clinical outcomes would improve, and post-operative complication rate will be reduces in malnourished CD patients receiving pre-operative 4 weeks EEN during the 4 weeks post-surgery, compared to CD patients receiving high energy and protein diet without EEN.
详细描述
Study design:
A randomized, none-blinded study. Study population: 144 CD patients designated for surgery, 96 malnourished patients and 44 well-nourished patients. Participants will be recruited from the Department of Gastroenterology, from Surgery Department and from the Nutrition Unit in the Tel Aviv Medical Center (TLVMC).
Study procedure CD patients who are awaiting surgery will be screened and randomly assigned to the study. After the decision to perform surgery and patient's acceptance to participate in the study but not more than 3 months before scheduled surgery, patient will undergo nutritional assessment. Patients suffering from malnutrition will be randomly assigned to the EEN group or to the group receiving enriched high energy and protein diet. Well-nourished patients will continue with standard nutritional therapy. Malnutrition will be defined according to Subjective Global Assessment (SGA)
Screening procedure:
Patients assigned to the interventional arm would be asked to adhere to EEN for two days prior to inclusion in order to assess tolerability and adherence to the assigned diet. Those who are not able to adhere to a two day EEN diet , will be withdrawn from the interventional arm, and will be treated with a high energy, high protein diet as the control group in accordance to the study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD patients awaiting surgery
排除标准
- •Pregnancy and lactation
- •Subjects on TPN
- •Subjects with chronic conditions such as cancer, organ transplant subjects, advanced kidney or liver disease, systemic inflammatory conditions other than IBD
- •Inability to sign informed consent and complete study protocol
- •Surgical procedure to reverse ileostomy/colostomy or abscess drainage
结局指标
主要结局
Changes in adherence to therapy
时间窗: during every study visit week 1, week 2, week 3, week 4, 30 days post - surgery
During every study visit week 1, week 2, week 3, week 4, 30 days post - surgery, MARS, Medication Adherence Rating Scale - questionnaire filled by subject: Patient asked to respond to the statements in the questionnaire by circling the answer best describes their behavior or attitude towards their diet prescription during the past week. Score range between: min of 10-19 - no adherence to diet, 40-49 often adherence, 50 max score present permanent adherence.
Changes in tolerability to the diet
时间窗: Tolerance will be monitored during every study visit: week 0, week 1, week 2, week 3, week 4
Tolerance will be monitored during every study visit week 0, week 1, week 2, week 3, week 4, as ingestion of the entire amount of formula requested by the patient without the development of any allergic/intolerant symptoms, report on changes in tolerance documented and monitored in tailored form.
Changes in Compliance to diet
时间窗: during every study visit week 0, week 1, week 2, week 3, week 4, 30 days post - surgery
During every study visit compliance to diet instructed, monitor every week since initiating: week 0, week 4, 30 days post - surgery by 3 days food diary calculated average consumption of kcal and protein in grames. The same assessment carried out at week 1, week 2, week 3, by 24 - hour recall questionnaire. High Compliance considered if Calories \> 80% protein ≥ 1 gr/kg from the expected metabolic assessment needs for each week 1-4 dietary intervention, and present better outcomes. 1. using the MARS questionnaire - Medication Adherence Rating Scale. The patient should be asked to respond to the statements in the questionnaire by circling the answer which best describes their behaviour or attitude towards their medication during the past week. 2. Patients will fill-up a 3 day food diary during every study visit to assesses recent dietary composition
次要结局
- The rate of post-operative complications in malnourished CD patients receiving pre-operative 4 weeks EEN, is changed during the 4 weeks post-surgery, compared to CD patients receiving high energy and protein diet without EEN one month after surgery.(One month after surgery)
研究者
michal roll
Director, R&D Department
Tel-Aviv Sourasky Medical Center