Exploring the effects of postbiotics on elderly hemodialysis patients
A Postbiotics Improves the Quality of Life and Nutritional Status in Elderly Hemodialysis Patients
This study is testing if a new postbiotics product can improve the quality of life and nutrition for elderly patients on hemodialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06975995 on ClinicalTrials.gov |
What this trial studies
This trial investigates the impact of exogenous postbiotics on the quality of life and nutritional status of elderly patients undergoing hemodialysis. Participants aged 65 and older will be randomly assigned to receive either a postbiotics product or a placebo for 12 weeks, followed by a crossover period where the placebo group will receive the postbiotics. The study aims to assess changes in quality of life and nutrition through various indicators over the treatment period. It is a multicenter, prospective, open-label, randomized controlled trial designed to provide insights into the benefits of postbiotics for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are elderly individuals aged 65 and older who have been on maintenance hemodialysis for at least six months.
Not a fit: Patients with recent gastrointestinal issues or conditions affecting oral feeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life and nutritional status of elderly patients on hemodialysis.
How similar studies have performed: While the specific use of postbiotics in this context is novel, similar studies have shown promising results in improving health outcomes in patients with chronic conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Peking UFH — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yuqing Chen
- Email: cyq@bjmu.edu.cn
- Phone: 86-010-82572254
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.