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Effect of the Lactobacillus Plantarum strain on symptoms in patients with hypercholeaterolemia: a randomized controlled trial.

Effect of the Lactobacillus Plantarum strain on symptoms in patients with hypercholeaterolemia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033846
Enrollment
Unknown
Registered
2020-06-14
Start date
2020-06-03
Completion date
Unknown
Last updated
2020-06-15

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

Conditions

hypercholesterolemia

Interventions

Sponsors

Jiangnan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Total cholesterol (TC) > 5.17 mmol/L(200 mg/dL), or total triglyceride (TG) > 2.3 mmol/L(200 mg/dL) or low-density lipoprotein (ldl-c >3.64 mmol/L), or high-density lipoprotein (hdl-c < 1.0 mmol/L); (2) Age between 18 to 75 years old, male or female; (3) Did not participate in other studies in recent 3 months; (4) Understand the ability of learning requirements, and commit to cooperate with the research during the whole experiment; (5) Willing to provide written informed consent, basic information questionnaire; (6) No addiction to tobacco, alcohol or drug abuse and other adverse phenomena.

Exclusion criteria

Exclusion criteria: (1) Patients with severe cardiopulmonary, brain, vascular diseases, liver and kidney diseases, tumor diseases; (2) Pregnant or lactating women; (3) Patients who administered probiotics, antibiotics or research products in the one month prior to inclusion will also be excluded; (4) Subjects having mental illness, which may cause difficulties in cooperation; (5) Patients lack of self-judgment; (6) Alcohol or drug abusers; (7) Subjects participating in other clinical trials; (8) Unwilling or unable to provide written informed consent to participate in the study after notifying the the purpose, process and possible risks; (9) Subjects who fail to meet the requirements of the study or who is considered unsuitable for the study.

Design outcomes

Primary

MeasureTime frame
Fecal Metagenome;Fecal short chain fatty acid ;Total Cholesterol;triglyceride;high density lipoprotein cholesterol ;low density lipoprotein cholesterin ;Systolic blood pressure ;diastolic blood pressure ;Fasting blood glucose ;Blood biochemical examination;Blood routine examination ;routine urine test;occult blood test;liver function test;kidney function test ;

Countries

China

Contacts

Public ContactQixiao Zhai

School of Food Science and Technology, Jiangnan University

zhaiqixiao@jiangnan.edu.cn+86 15961760920

Outcome results

None listed

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