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Effect of Quadruple Probiotic Combined with Dietary Fiber on Modulating Gut Microbiota for Treating Sarcopenia in the Elderly: A Clinical Study (Note: Ongoing, retrospectively registered. Filed in the Medical Research Registration and Filing Information System, Filing No.: MR-11-24-048539)

Effect of Quadruple Probiotic Combined with Dietary Fiber on Modulating Gut Microbiota for Treating Sarcopenia in the Elderly: A Clinical Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108885
Enrollment
Unknown
Registered
2025-09-08
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Sarcopenia

Interventions

Control group:Exercise (resistance exercise + aerobic exercise) and nutrition (protein supplementation) treatment were given for a period of 6 months
Intervention group:Exercise (the same as the control group), nutrition (the same as the control group) + Bifidobacterium quadruple live bacteria tablets, 3 times a day, 3 tablets (1.5g) each time + wa

Sponsors

Department of Geriatrics (General), Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 95 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 65-95 years old with a clear diagnosis of sarcopenia: according to the diagnostic criteria of the Asian Working Group for Sarcopenia (AWGS), that is, skeletal muscle mass reduction, muscle strength decline and/or physical dysfunction; 2. Patients who can fully understand the content of informed consent in this trial and voluntarily sign the written informed consent form, and those who have not participated in other interventional studies within 6-12 months.

Exclusion criteria

Exclusion criteria: 1. Use of antibiotics or probiotics within 4 weeks prior to enrollment; 2. Those who participate in other clinical trials; 3. Severe liver or kidney disease (liver function: ALT> = 3 times the upper limit of normal; renal function: dialysis-treated patients or estimated glomerular filtration rate [eGFR] 2.5 mg/dl [>221 mmol/L]); 4. Have a history of stroke (large artery atherosclerotic cerebral infarction or hemorrhagic stroke, but lacunar infarction and transient ischemic attack (TIA) are not excluded); 5. History of coronary heart disease: including hospitalization for acute myocardial infarction or unstable angina pectoris in the past 6 months; Revascularization surgery (PCI or CABG) within the last 12 months; Those who plan to undergo revascularization surgery (PCI or CABG) within the next 6 months; 6. Accompanied by NYHAIII, IV grade heart failure at the time of screening or hospitalization due to aggravation of chronic heart failure in the past 6 months; 7. Dilated or hypertrophic cardiomyopathy, rheumatic heart disease, congenital heart disease; 8. Patients with previously diagnosed dementia, advanced Parkinson's disease, intracranial infection or tumor, schizophrenia, depression; 9. Previous neurosurgery; 10. Alcoholism or taking drugs that affect cognitive function (antihistamines, psychiatric drugs, etc.); 11. Have undergone general anesthesia surgery within 3 months; 12. Those who have other serious diseases that may hinder their enrollment or affect their survival, such as malignant tumors or AIDS, and have a life expectancy of < 1 year; 13. Those who have communication difficulties or are unable to take care of themselves; 14. Have special dietary habits, such as vegetarianism; 15. Non-compliance with the experimental protocol.

Design outcomes

Primary

MeasureTime frame
Grip strength;

Secondary

MeasureTime frame
6-meter walking speed;Appendicular Skeletal Muscle Mass Index(ASMI);Frailty Phenotype (Fried Criteria);SARC-CalF Questionnaire Score;Mini-mental state examination(MMSE);Montreal Cognitive Assessment(MoCA) Score;Instrumental Activities of Daily Living Scale Score;Nutritional Risk Screening 2002 (NRS-2002) Score;Circulating Inflammatory Biomarkers;Gut Microbiota;Body Mass Index;Blood Lipids;

Countries

China

Contacts

Public ContactYang Wei

Xuanwu Hospital, Capital Medical University

yangw_79@163.com+86 138 1149 1582

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026