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:
1. In the treatment period for 12 weeks, intervention group receives postbiotics product while the other group receives placebo. 2. 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.
Age ≥65 years.
Receiving maintenance hemodialysis therapy for at least 6 months.
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.
Crossover
Yi'en Yuan Honey Fermented Drink
Dietary supplementThe oral postbiotics product used in the trial is called Yi'en Yuan Honey Fermented Drink. The product is made from water, edible brown sugar, and honey as raw materials. It is fermented by a mixture of plant lactic acid bacteria and coagulating Bacillus, and then inactivated at high temperature. The product meets the food and beverage standard. Participants will receive the product for 150ml per day.
Changes of nutritional status from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group.
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.
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.
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.
Asthenia of the patients is defined as the scores of edmonton frail Scale (EFS).
Changes of IS level from baseline to the end of treatment and difference between the intervention and placebo group.
Enterogenous urotoxin level is defined as the serum level of IS. The levels of serum IS will be measured by mass spectrometry.
Changes of TMAO level from baseline to the end of treatment and difference between the intervention and placebo group.
Enterogenous urotoxin level is defined as the serum level of TMAO. The levels of serum TMAO will be measured by mass spectrometry.
Changes of PCS level from baseline to the end of treatment and difference between the intervention and placebo group.
Enterogenous urotoxin level is defined as the serum level of PCS. The levels of serum PCS will be measured by mass spectrometry.
Changes of hemoglobin from the baseline to the end of treatment, and differences between the intervention group and the placebo group.
The levels of hemogolbin (g/L).
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