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A Randomized, Double-Blind, Placebo-Controlled Trial of Quadruple Live Bifidobacterium in Patients With Heart Failure With Preserved Ejection Fraction

Effects of Bifidobacterium Quadruple Live Bacteria on Cardiac Function, Inflammatory Response, and Quality of Life in Patients with Heart Failure with Preserved Ejection Fraction: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120297
Enrollment
Unknown
Registered
2026-03-11
Start date
2026-03-11
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiovascular medicine

Interventions

Control Intervention:Quadruple Live Bifidobacterium Intervention

Sponsors

Guidong People’s Hospital of Guangxi Zhuang Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients meeting the diagnostic criteria for heart failure with preserved ejection fraction (HFpEF) according to the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure and the Chinese Expert Consensus on the Diagnosis and Treatment of Heart Failure with Preserved Ejection Fraction (2025 Edition); aged 18 years or older, regardless of sex; New York Heart Association (NYHA) functional class I–III; clinically stable heart failure symptoms on the basis of standard therapy and able to comply with the study protocol; voluntarily providing written informed consent and able to participate in and complete the study.

Exclusion criteria

Exclusion criteria: Participants will be excluded if they have used or are currently using probiotic preparations within 7 days before enrollment; have serious comorbidities, including malignant tumors, hyperthyroidism, severe chronic obstructive pulmonary disease, severe infections requiring antibiotic treatment, electrolyte disturbances, poorly controlled blood glucose, or motor dysfunction; are pregnant or breastfeeding women; have severe hepatic or renal dysfunction; are receiving and unable to discontinue medications that may affect the action of probiotics, such as antibiotics; have cardiogenic shock, severe arrhythmias, recent cardiac resynchronization therapy, heart transplantation, or mechanical circulatory support; have heart failure secondary to structural heart disease, congenital heart disease, myocarditis, cardiac tumors, or recent acute myocardial infarction; have known allergy to any component of the probiotic preparation; have intestinal diseases that may interfere with the gut microbiota, including intestinal infection, inflammatory bowel disease, intestinal obstruction, or colon cancer; are unable to undergo echocardiographic examination; are unable or unwilling to comply with the study-required diet and lifestyle regimen; are immunocompromised or receiving immunosuppressive therapy; or have any other condition that, in the opinion of the investigators, makes them unsuitable for participation in the trial.

Design outcomes

Primary

MeasureTime frame
Cardiac Function Parameters;

Secondary

MeasureTime frame
inflammatory factors;Health-Related Quality of Life;

Countries

China

Contacts

Public ContactCen Kaiyuan

Guidong People’s Hospital of Guangxi Zhuang Autonomous Region

cky163163@163.com+86 150 3056 7756

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026