NCT06975995 Effect of the Postbiotics on Complications Treatment in Elderly Hemodialysis Patients
| NCT ID | NCT06975995 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University First Hospital |
| Condition | Hemodialysis Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-08-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Yuqing Chen
STUDY CHAIR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT06975995 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Hemodialysis Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06975995 currently recruiting?
Yes, NCT06975995 is actively recruiting participants. Contact the research team at cyq@bjmu.edu.cn for enrollment information.
Where is the NCT06975995 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06975995 clinical trial?
NCT06975995 is sponsored by Peking University First Hospital. The principal investigator is Yuqing Chen at Peking University First Hospital. The trial plans to enroll 60 participants.