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临床试验/NCT06724185
NCT06724185已完成不适用

Effects of LP28 on Immunity Enhancement in the Elderly

Synbio Tech Inc.4 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年7月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
4
主要终点
WURSS-24

研究概览

简要总结

Due to the increasing attention on aging-related health issues, this study focuses on the elderly population as participants. The aim is to investigate whether supplementation with Lactobacillus plantarum LP28 can effectively enhance immunity, reduce the frequency and severity of common cold infections, and ultimately promote overall health in the elderly.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Those who had symptoms of common cold or tonsillitis at least twice in the past year.

排除标准

  • People who have liver, kidney, immune, or neoplastic diseases diagnosed by doctor.
  • People with mental illnesses such as schizophrenia or depression.
  • People who have allergic rhinitis.
  • People who have a current condition of drug or alcohol dependence.
  • Any person is deemed inappropriate by the researcher for the clinical trial.

研究组 & 干预措施

LP28 capsule

Experimental

Subjects will take two capsule of the experimental group(LP28 capsule) within 30 minutes before breakfast and dinner each day.

干预措施: LP28 capsule (Dietary Supplement)

Placebo capsule

Placebo Comparator

Subjects will take two placebo capsule within 30 minutes before breakfast and dinner each day.

干预措施: Placebo Capsule (Dietary Supplement)

结局指标

主要结局

WURSS-24

时间窗: From enrollment to the end of treatment at 12 weeks (measure daily)

The WURSS-24 (Wisconsin Upper Respiratory Symptom Survey-24) is a questionnaire designed to assess the impact of upper respiratory tract infections, such as the common cold, on daily life and health. It includes 24 questions covering symptoms (e.g., cough, runny nose, fatigue) and how they affect daily activities, work, and social interactions. Patients rate each item on a scale from 0 (no problem) to 7 (severe problem).

次要结局

  • Immune cell ratio(From enrollment to the end of treatment at 12 weeks (measure every 6 weeks))
  • NK cell activity(From enrollment to the end of treatment at 12 weeks (measure every 6 weeks))
  • Cytokines measurement(From enrollment to the end of treatment at 12 weeks (measure every 6 weeks))
  • sIgA(From enrollment to the end of treatment at 12 weeks (measure every 6 weeks))
  • α-amylase(From enrollment to the end of treatment at 12 weeks (measure every 6 weeks))
  • GSRS questionnaire(From enrollment to the end of treatment at 12 weeks (measure weekly))
  • Defecation frequency and stool pattern(From enrollment to the end of treatment at 12 weeks (measure weekly))

研究者

发起方
Synbio Tech Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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