An interventional study of Yi'en Yuan Honey Fermented Drink in Hemodialysis Complication, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Peking University First Hospital · Not applicable, Interventional, and Treatment
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:
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.
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.
Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
The following exclusion criteria must NOT be present for each subject:
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.
Dietary Supplement: Yi'en Yuan Honey Fermented Drink
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.
Dietary Supplement: Yi'en Yuan Honey Fermented Drink
The 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.
Time frame: baseline, the 12th week of treatment period
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).
Time frame: baseline, the 12th week of treatment period
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) .
Time frame: baseline, the 12th week of treatment period
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).
Time frame: baseline, the 12th week of treatment period
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.
The BMI (kg/m2) of the patients.
Time frame: baseline, the 12th week of treatment period
Changes of dry weight from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group.
The dry weight of the patient is obtained from the bioelectrical impedance analysis.
Time frame: baseline, the 12th week of treatment period
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.
Time frame: 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.
Enterogenous urotoxin level is defined as the serum level of TMAO. The levels of serum TMAO will be measured by mass spectrometry.
Time frame: 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.
Enterogenous urotoxin level is defined as the serum level of PCS. The levels of serum PCS will be measured by mass spectrometry.
Time frame: 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.
The levels of hemogolbin (g/L).
Time frame: 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.
The levels of albumin (g/L)
Time frame: 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.
The levels of BUN (mmol/L).
Time frame: baseline, the 12th week of treatment period
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — The data of participants of the study will keep confidential and there is no plan to share IPD to other researchers.
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Peking University First Hospital