Hemodialysis ComplicationNCT06975995
Effect of the Postbiotics on Complications Treatment in Elderly Hemodialysis Patients
A study testing Yi'en Yuan Honey Fermented Drink in people with Hemodialysis Complication, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Yi'en Yuan Honey Fermented Drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking UFH
Beijing, Beijing Municipality, 100034
Yuqing Chen, PhD, 15910285602, cyq@bjmu.edu.cn
Di Song, PhD, 15201303625, hellosongdi@163.com
About this study
Official title: A Postbiotics Improves the Quality of Life and Nutritional Status in Elderly Hemodialysis Patients
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Hemodialysis Complication
- Being tested
- Yi'en Yuan Honey Fermented Drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yi'en Yuan Honey Fermented DrinkDietary supplement
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 group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | 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. Receives: Dietary Supplement: Yi'en Yuan Honey Fermented Drink |
| Placebo group | Placebo comparator | 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. Receives: Dietary Supplement: Yi'en Yuan Honey Fermented Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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) .
Measured: 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).
Measured: 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.
Measured: 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.
Measured: baseline, the 12th week of treatment period
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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).
Measured: baseline, the 12th week of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuqing Chen, Study chair, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975995
- Sponsor's protocol ID
- Bio-EHD
- Status last verified
- Jun 2024
- First submitted
- 2 Jun 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data of participants of the study will keep confidential and there is no plan to share IPD to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Postbiotics Improves the Quality of Life and Nutritional Status in Elderly Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06975995
- Acronym / sponsor ID
- Bio-EHD
- Conditions
- Hemodialysis Complication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Dietary Supplement: Yi'en Yuan Honey Fermented DrinkThe 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. |
| Placebo group | Placebo comparator | Dietary Supplement: Yi'en Yuan Honey Fermented DrinkThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yi'en Yuan Honey Fermented DrinkThe 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. | Dietary supplement | Intervention group, Placebo group |
Primary outcome
Changes of nutritional status from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, the 12th week of treatment period
The dry weight of the patient is obtained from the bioelectrical impedance analysis.
6 secondary outcomes
Changes of IS level from baseline to the end of treatment and difference between the intervention and placebo group.
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.
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.
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.
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.
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.
Time frame: baseline, the 12th week of treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuqing Chen study chair
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yi'en Yuan Honey Fermented Drink in people with Hemodialysis Complication, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuqing Chen (86-010-82572254, cyq@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of nutritional status from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group. (time frame: baseline, the 12th week of treatment period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.