A Postbiotics Improves the Quality of Life and Nutritional Status in Elderly Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes of nutritional status from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group.
研究概览
简要总结
The purpose of the trial is to explore the effect of exogenous postbiotics supply on the quality of life and nutritional status of elderly hemodialysis patients.
Participants will be devided into intervention group and placebo group in an 1:1 ratio.They will:
- In the treatment period for 12 weeks, intervention group receives postbiotics product while the other group receives placebo.
- In the subsequent 12 weeks, intervention group ends the trial and placebo group enters into remedial treatment period. Placebo group will receive postbiotics product for 12 weeks.
Researchers will analyze the change of indicators such as quality of life and nutrition state of participants from the baseline to end of treatment, and compare the difference between the two group.
详细描述
Intestinal flora imbalance has a high prevalence in CKD patients and is closely invloved with CKD complications like malnutrition and anemia, which affects quality of life and long-term prognosis of CKD patients. Probiotics is the bioactive compound produced by probiotics when it consumes prebiotics. It can alleviate the condition and improve quality of life of patients by regulating growth of microbiota directly and indirectly and inhibiting growth of pathogenic microorganism. The purpose of the trial is to explore the effect of exogenous postbiotics supply on the quality of life and nutritional status of elderly hemodialysis patients.
The study is a multicenter prospective open-labled and randomized controlled trial. Elderly patients with age ≥65 years and received hemodialysis treatment for more than 6 months will be included in the study. During the screen period, the patients with medical history that might affect oral feeding or gastrointestinal functions will be excluded.
After enrollment, the patients will be educated about how to keep diet records and then they will be randomly divided into group A (intervention group) and group B (placebo group) in an 1:1 ratio. The patients in group A will receive oral postbiotics and group B receive placebo. The treatment period is 12 weeks. Subsequently, group A ends the trial, and group B enters the remedial treatment period, receiving oral postbiotics, and the treatment cycle is 12 weeks.
At 0, 12 and 24 weeks quality of life score, nutrition evaluation, diet status and gastrointestinal symptom score respectively will be evaluated. The stool and serum of patients will be collected for intestinal flora and urotoxins measurements. Besides, the trial will collect routine biochemical indicators. The investigators will analyze those indicators above from the baseline to end of treatment and compare the difference between intervention group and placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Investigators must maintain a screening log of all potential study candidates that includes limited information about the potential candidate, date, and outcome of the screening process (e.g. enrolled into study, reason for ineligibility, or refused to participate). After signing an informed consent form, potential patients must meet all of the criteria:
- •Age ≥65 years.
- •Receiving maintenance hemodialysis therapy for at least 6 months.
排除标准
- •The following exclusion criteria must NOT be present for each subject:
- •Subjects with medical history that might affect oral feeding (e.g. intestinal obstruction, gastrointestinal bleeding, acute pancreatitis and accidental inhalation) within the last 1 month prior to screening.
- •Subjects with medical history that might affect gastrointestinal functions (e.g. inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), short bowel syndrome (SBS), et al.).
- •Subjects who cannot communicate and collaborate normally.
研究组 & 干预措施
Intervention group
The intervention group will receive oral postbiotics product for 150ml per day during the treatment period (from week 1 to week 12). Then, the group will end the trial.
干预措施: Yi'en Yuan Honey Fermented Drink (Dietary Supplement)
Placebo group
The placebo group will receive oral placebo during the treatment period (from week 1 to week 12). Then, the group will enter into remedial the treatment period (from week 13 to week 24) and receive the same oral postbiotics product as intervention group for 150ml per day. The group will end the trial at week 24.
干预措施: Yi'en Yuan Honey Fermented Drink (Dietary Supplement)
结局指标
主要结局
Changes of nutritional status from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group.
时间窗: baseline, the 12th week of treatment period
Nutritional status of the patient is defined as the results of physical examination and SGA-7 rating scale.
Changes of gastrointestinal symptoms from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group.
时间窗: baseline, the 12th week of treatment period
Gastrointestinal symptoms of the patient is defined as the scores of gastrointestinal symptom rating scale (GSRS).
Changes of quality of life from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group.
时间窗: baseline, the 12th week of treatment period
Quality of life of the patient is defined as the scores of kidney disease life quality scale (SF-36) .
Changes of asthenia of the patients from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group.
时间窗: baseline, the 12th week of treatment period
Asthenia of the patients is defined as the scores of edmonton frail Scale (EFS).
Changes of body mass index from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group.
时间窗: baseline, the 12th week of treatment period
The BMI (kg/m2) of the patients.
Changes of dry weight from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group.
时间窗: baseline, the 12th week of treatment period
The dry weight of the patient is obtained from the bioelectrical impedance analysis.
次要结局
- Changes of IS level from baseline to the end of treatment and difference between the intervention and placebo group.(baseline, the 12th week of treatment period)
- Changes of TMAO level from baseline to the end of treatment and difference between the intervention and placebo group.(baseline, the 12th week of treatment period)
- Changes of PCS level from baseline to the end of treatment and difference between the intervention and placebo group.(baseline, the 12th week of treatment period)
- Changes of hemoglobin from the baseline to the end of treatment, and differences between the intervention group and the placebo group.(baseline, the 12th week of treatment period)
- Changes of albumin from the baseline to the end of treatment, and differences between the intervention group and the placebo group.(baseline, the 12th week of treatment period)
- Changes of BUN from the baseline to the end of treatment, and differences between the intervention group and the placebo group.(baseline, the 12th week of treatment period)