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NCT05724511
The Effect of Probiotics on Depression Syndrome and Risk Factors of Cardiovascular Disease in Hemodialysis Patients
Conditions: Depression Mild, Cardiovascular Diseases
Sex: All
Ages: 20 Years – N/A
Phase: PHASE4
Enrollment: 70
Sponsor: China Medical University Hospital
Summary
As the investigators know, only few researches focus on the effect of probiotics on depression in hemodialysis patients.
Besides, probiotics also have benefit effect on dyslipidemia and hypertension in general population.
Both of them are the risk factors of cardiovascular disease which is the major cause of death in hemodialysis patients.
Therefore, this study looks for the effect of probiotics on depression syndrome and risk factors of cardiovascular disease in hemodialysis patients.
This is a randomized controlled trial.
All patients will be assigned at random to intervention group or control group.
This study plans to recruit 70 hemodialysis patients and expects at least 30 patients in each group at the end of study period.
The investigators provide probiotics (C.
butyricum MIYAIRI 588) to intervention group and provide nothing to the control group.All patients need to maintain the lifestyle during study period.
Genomic analysis of gut microbiota on patients' fecal samples will be used to evaluation their compliance.
Eligibility Criteria
Inclusion Criteria:Adults aged 20 years or older undergoing hemodialysis (at least 3 months), 3 times per week, and URR ≥65%Exclusion Criteria:allergic to the components of the intervention drug, low tolerance of milk or dairy productsHas the diagnosis of dementia, delirium, bipolar disorder, schizophrenia, or liver failureBeck Depression Inventory Chinese version 2.0 score higher than 14, or has significant suicide risk during studyFollowing significantly clinical syndrome: obsessive compulsive disorder, schizoid personality disorder, schizotypal personality, paranoid、antisocial Personality Disorder, histrionic personality disorderWith addiction to alcohol or drugs, terminal cancer, severe infection, heart failure, central venous catheter in the past 6 monthsTaking antibiotics, anti-oxidant vitamin supplement, probiotics, prebiotics, antidepressants, anti-anxiety medicine, yogurt and the products in the past 3 monthsPregnant or lactating
Source: ClinicalTrials.gov (NCT05724511). StuddyBuddy aggregates publicly available trial information.