Evaluating the Potential of Probiotic Supplementation Sleep Quality
NCT Number: NCT06486064
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep Disorder|Anxiety|Depression|Stress|Probiotics
Interventions: DIETARY_SUPPLEMENT: heat-treated Limosilactobacillus fermentum|DIETARY_SUPPLEMENT: Placebo
Sponsor: Chi-Chang Huang
Collaborators: Bened Biomedical Co., Ltd.
Sex: ALL
Age: ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-07-30
Completion Date: 2025-12-31
Locations: Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan, 33301, Taiwan

Summary:
This study aims to evaluate the feasibility of probiotics in improving sleep indicators through clinical human studies. Previous animal experiments have confirmed that Limosilactob acillus fermentum PS150 and heat-treated Lactobacillus fermentum HT-PS150 strains have the effect of improving sleep. 90 subjects will be recruited, 45 in each group. They will be given either HT-PS150 or placebo for 8 weeks and their blood, urine, saliva and questionnaire will be evaluated.

Primary Outcome Measures: Pittsburgh sleep quality index, PSQI, The Pittsburgh Sleep Quality Index contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality)., From baseline to 8 weeks assessed|Insomnia severity index, ISI, The ISI is a 7-item patient-reported outcome measure (PROM) assessing the nature, severity, and impact of insomnia on a 5-point Likert scale to rate each item from 0 (no problem) to 4 (very severe problem)., From baseline to 8 weeks assessed
Secondary Outcome Measures: Total sleep time, Compare the sleep times on the Fitbit, From one week before baseline to 8 weeks assessed|Change in Generalised Anxiety Disorder Assessment (GAD-7), The Generalised Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Response options include "not at all", "several days", "more than half the days" and "nearly every day", From baseline to 8 weeks assessed|Change in Depression Score Patient Health Questionnaire (PHQ-9), The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression: The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool.Depression Severity: 0- none, 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression., From baseline to 8 weeks assessed|Change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16, The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 is a valid, reliable self-report instrument for assessing quality of life. The minimum raw score on the Q-LES-Q-16 is 14, and the maximum score is 70, higher scores mean a better outcome., From baseline to 8 weeks assessed|Change in Visual Analogue Scale-GI (VAS-GI), Visual Analogue Scale for GI symptoms, VAS-GI (visual analogue scale, VAS 0-10) was designed to measure the response of symptoms and well-being in patients after taking probiotics or placebo., From baseline to 8 weeks assessed|Patient Global Impression scales of Improvement rated by patient（PGI-C）, The PGIC consists of one item taken from the clinical global impression and adapted to the patient. The minimum total score possible is 1 and the maximum total score possible is 7. Higher values represent a worse outcome., From baseline to 8 weeks assessed|Change in Melatonin in both blood and saliva, From baseline to 8 weeks assessed|Change in Cortisol in both blood and saliva, Cortisol is a steroid hormone that is produced by the adrenal glands which sit on top of each kidney. When released into the bloodstream, cortisol can act on many different parts of the body and can help: body respond to stress or danger increase body's metabolism of glucose control blood pressure reduce inflammation. Cortisol is also needed for the fight or flight response which is a healthy, natural response to perceived threats. The amount of cortisol produced is highly regulated by body to ensure the balance is correct., From baseline to 8 weeks assessed|Change in Total Antioxidant Capacity , TAC, Levels of Total Antioxidant Capacity , TAC in serum, From baseline to 8 weeks assessed|Change in GABA in both blood and saliva, GABA is known for producing a calming effect. It's thought to play a major role in controlling nerve cell hyperactivity associated with anxiety, stress and fear., From baseline to 8 weeks assessed|Change in Serotonin in both blood and saliva, Serotonin is a chemical that carries messages between nerve cells in the brain and throughout your body. Serotonin plays a key role in such body functions as mood, sleep, digestion, nausea, wound healing, bone health, blood clotting and sexual desire. Serotonin levels that are too low or too high can cause physical and psychological health problems., From baseline to 8 weeks assessed|Change in Orexin in both blood and saliva, Orexin, From baseline to 8 weeks assessed|Change in 6 sulfatoxymelatonin in urine, 6 sulfatoxymelatonin, From baseline to 8 weeks assessed|Change in Norepinephrine in both blood and urine, Norepinephrine, From baseline to 8 weeks assessed|Changes in Interleukin-6 (IL-6) in saliva, changes in IL-6 blood serum concentration levels in serum experimental group (in comparison to placebo control), From baseline to 8 weeks assessed|Change in Gut microbiome, The gut microbiome plays important roles in both the maintenance of health and the pathogenesis of disease. Stool will be examined before and after probiotics., From baseline to 8 weeks assessed|Sleep quality, Compare the sleep score recorded on the Fitbit, From baseline to 8 weeks assessed