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.
Study summary
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.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
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:
1. Age ≥65 years.
2. Receiving maintenance hemodialysis therapy for at least 6 months.
Exclusion Criteria:
The following exclusion criteria must NOT be present for each subject:
1. 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.
2. 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.).
3. Subjects who cannot communicate and collaborate normally.
Primary outcome measure(s)
Changes of nutritional status from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group. — 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. — 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. — 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. — 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. — 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. — baseline, the 12th week of treatment period The dry weight of the patient is obtained from the bioelectrical impedance analysis.
Trial sites (1)
Facility
City
Region
Status
Peking UFH
Beijing
Beijing Municipality
Recruiting
More Peking University First Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.