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临床试验/CTRI/2026/02/102862
CTRI/2026/02/102862尚未招募不适用

Investigation of the effects of Probiotics along with Exercise on the sleep quality among Indian Medical undergraduates.

ICMR Short Term Studentship Grant 20241 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年4月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Change in sleep quality, assessed pre- and post- intervention using Pittsburg Sleep Quality Index (PSQI)

研究概览

简要总结

Poor sleep quality is common among medical undergraduate students and is associated with stress, lifestyle factors, and impaired health. Regular physical exercise is known to improve sleep quality, while probiotics have been suggested to influence sleep and mental well-being through modulation of inflammatory and physiological processes.

This interventional study aims to assess the effect of probiotic supplementation along with regular exercise on sleep quality among medical undergraduate students and to compare the outcomes with exercise alone.

The study will be conducted among 60 undergraduate medical students aged 18–21 years at Jawaharlal Nehru Medical College, Belagavi, with impaired sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI). Participants will be randomly allocated into two groups: Control group will receive a standardized exercise regimen with placebo, and Experimental group will receive the same exercise regimen along with daily multi-strain probiotic supplementation for a period of eight weeks. Students with chronic medical illnesses, psychiatric conditions, or medication use affecting study outcomes will be excluded.

Sleep quality will be assessed using PSQI at baseline and at the end of the intervention. Blood samples will be collected at baseline and after eight weeks to assess inflammatory markers including TNF-alpha, IL-6, and IL-10. Pre- and post-intervention outcomes will be compared within and between the two groups to evaluate the effect of probiotics combined with exercise on sleep quality.

This study aims to expand the existing knowledge about probiotics and their effects on psychological well-being (psychobiotics). This can provide insights into the potential of probiotics and exercise as non-pharmacological interventions for sleep disorders, contributing to a better understanding of the gut-brain axis and its role in sleep regulation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • Healthy medical undergraduate students who are willing to comply with study protocols -Physically able to perform moderate exercise -Baseline poor or suboptimal sleep quality (PSQI more than 5).

排除标准

  • Diagnosed sleep disorders -Current psychiatric illness or use of psychotropic medications -GI impaired students already consuming probiotics -Regular use of sleep altering substances and devices -Chronic medical illnesses affecting sleep -Autoimmune disorders.

结局指标

主要结局

Change in sleep quality, assessed pre- and post- intervention using Pittsburg Sleep Quality Index (PSQI)

时间窗: Pittsburg Sleep Quality Index (PSQI) Score- assessed at baseline, 4 weeks and 8 weeks | Inflammatory markers (IL-10 and IL-6) will be assessed at Baseline and at the end of 8 weeks.

Secondary Outcome - Change in inflammatory markers (IL-10 and IL-6) measured using pre and post intervention blood samples

时间窗: Pittsburg Sleep Quality Index (PSQI) Score- assessed at baseline, 4 weeks and 8 weeks | Inflammatory markers (IL-10 and IL-6) will be assessed at Baseline and at the end of 8 weeks.

次要结局

  • Change in sleep quality, assessed pre- and post- intervention using Pittsburg Sleep Quality Index (PSQI)

研究者

发起方
ICMR Short Term Studentship Grant 2024
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Nirmiti Bhaven Mahadevia

MBBS Student, Jawaharlal Nehru Medical College, KAHER, Belagavi

研究点 (1)

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