Impact of Oral Nutritional Supplements on Nutritional, Gut Functional and Clinical Outcomes: a Randomized Controlled Trial in Patients Undergoing Haematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The between-group change for body weight
研究概览
简要总结
Malnutrition is common after haematopoietic stem cell transplantation (HSCT), and is a well-known prognostic factor for survival. HSCT-associated treatments are metabolic and digestively intolerant, hence can induce a significant reduction in oral intake. Thus weight loss, as well as a reduction in serum albumin, and pre-albumin levels, are frequent following HSCT. Although the gut remains functional, sore mouth, mucositis, dysphagia, nausea, vomiting, and diarrhoea will inevitably hinder the implementation of enteral nutrition (EN), thus leading to a deficit between daily intake and requirement. Side effects of chemotherapy and antibiotics in combine will contribute to the alteration of intestinal flora on top of the existing gut symptoms, further impairing nutrient digestion and absorption.
Oral nutritional supplements (ONS) are foods for special medical purposes (FSMP) that are specially formulated for oral nutritional support. Limited retrospective studies performed in Western countries have found that ONS was tolerable for HSCT patients eligible for EN, however, the data is sparse in China to support the safety of usage amongst this population. On the other side, what is less clear is the nature of soluble fiber upon the intestinal microenvironment in patients undergoing HSCT. It would be worthwhile to investigate the impact of fibre-modulated ONS on gut function and symptoms.
The study is a prospective study. All the participants will be recruited from a single research center (Renji Hospital). The participants will be randomized into two groups: traditional treatment or ONS. Ensure complete (Abbott), which contains soluble dietary fiber such as fructo-oligosaccharide (FOS) and inulin, will be served as the ONS for testing.
The primary aim of the study is to examine the between-group change from baseline body weight at 28 days post-transplantation. The secondary outcomes include the within-group and between-group dynamic change in the peri-transplant period for the following: body weight, fat-free mass, circumference, handgrip test, and patient-generated global subjective assessment. The tolerability of supplementing ONS and its' effect on gut function as well as on infection rate is also of interest.
详细描述
Standard Operating Procedures:
The study is located in Renji Hospital Stem Cell Transplant Unit, including Haematology Outpatient Department and Clinical Nutrition Department. All the patients aged between 18 and 75 years planned for HSCT and who are able to understand and sign an informed consent form are eligible for the study. The potential participants will be provided with the information sheet by the dietitian on the day of their outpatient pre-assessment visit. Each participant will be allocated with a study-specific code to protect their confidentiality. After recruitment, the participants will be asked to consume either the placebo control OR the ONS for testing, intended for supplementation for the duration of 7 days prior to HSCT admission. Anthropometry, biochemistry, and functional assessments are planned at four time points: before admission (baseline), the day of transplantation (D0), 14 days post-transplantation (D14) and 28 days post-transplantation (D28). In addition, nutritional intakes and gut assessments will be collected for the duration of the whole admission. If a subject is discharged home before D14 or D28, then these will be attempted at the appropriate time when the patient attended Haematology Outpatients for medical follow-up visits. Teleconsultation might be involved if the visit is not possible. All the data will be stored in an electronic database. It will be password protected with access only restricted to major investigators. All adverse events occurring within the trial will be collected at each visit for assessment of safety.
Sample Size Assessment:
A total number of 100 participants is determined necessary to demonstrate an effect. This sample size is designed to provide 85% power to detect a 1.2kg difference in body weight using an alpha=0.05(two-sided) to account for comparisons.
Plan for missing data:
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned for HSCT
- •No contraindications to enteral nutrition
- •Able to consent
排除标准
- •Existing contraindications to enteral nutrition
- •Existing infectious diarrhoea
- •Had other malignancies
- •Had gut surgery in a year
- •Had used prebiotics or probiotics or synbiotic in a month
- •Immunosuppressive OR prolonged corticosteroid therapy (more than three months)
- •Pregnancy or lactation
- •Had an allergy, or intolerance to ingredients of dietary supplements
- •Judged to be unsafe to tolerate fiber
研究组 & 干预措施
Placebo Control
干预措施: Traditional Control (Dietary Supplement)
Oral Nutritional Intervention
干预措施: Oral Nutritional Supplement (Dietary Supplement)
结局指标
主要结局
The between-group change for body weight
时间窗: Change from baseline in body weight at 28 days post transplantation
Body weight is assessed in kilograms
次要结局
- The within-group change for body weight(Change from baseline in body weight at the day of transplantation, 14 days post transplantation and 28 days post transplantation)
- The within-group and between-group change for fat free mass(Change from baseline in fat free mass at the day of transplantation, 14 days post transplantation and 28 days post transplantation)
- The within-group and between-group change for calf circumference(Change from baseline in calf circumference at the day of transplantation, 14 days post transplantation and 28 days post transplantation)
- The within-group and between-group change for handgrip test(Change from baseline in handgrip test at the day of transplantation, 14 days post transplantation and 28 days post transplantation)
- The within-group and between-group change for Patient-Generated Subjective Global Assessment(Change from baseline in PG-SGA at 28 days post transplantation)
- The between-group change for infection rate(at 28 days post transplantation)
- The within-group and between-group change for microbiota diversity(Change from baseline in faecal microbe diversity as well as gut microbiota-derived metabolites in urine and blood at the day of discharge)
- The within-group and between-group change for gut symptoms(Change from baseline in gut symptoms at the day of transplantation, 14 days post transplantation and 28 days post transplantation)
- The tolerability of supplementing the standard polymeric formula in the targeted population(at 28 days post transplantation)