Clinical trial NCT06486064: Evaluating the Potential of Probiotic Supplementation Sleep Quality
Official title: Evaluating the Potential of Probiotic Supplementation Sleep Quality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disorder
Anxiety
Depression
Stress
Probiotics
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
Collaborators: name: Bened Biomedical Co., Ltd.
First posted: 2024-07-03
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: The most important function of sleep is to restore physical energy lost after activities during the day, and to adjust and reorganize people's emotions, behavior, and cognitive memory. The average adult sleeps about 7 to 8 hours. Good sleep quality has a great impact on the performance of work and study during the day. If a person does not get enough sleep for a long time, it is easy to suffer from memory loss, emotional instability and other phenomena. It will also affect the operation of the immune system and easily lead to colds and illnesses. The following statements are often complained by sleep disorder patient: 1. Difficulty falling asleep. 2. Difficulty maintaining sleep, often waking up suddenly in the middle of sleep or having difficulty falling back to sleep once woken up. 3. Waking up too early and having trouble falling back to sleep. 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.

Eligibility criteria: Inclusion Criteria:

* Age 20 to 60 years old
* Pittsburgh Sleep Quality Scale score is greater than or equal to 5
* Insomnia Severity Scale (ISI less than 22 points)
* Subjects need to have a regular daily routine (no night shift work)

Exclusion Criteria:

* Have used antibiotics or probiotic products in powder, capsule or tablet form within one month
* Are taking drugs that may affect sleep (for example: sleeping pills, antipsychotic drugs, corticosteroids, antihistamines, stimulants, etc.) or undergoing hormonal treatment (including birth control pills)
* Those who are taking traditional Chinese medicine or western medicine to treat serious acute diseases
* Patients with uncontrolled high blood pressure or diabetes, a history of cancer, and mental illness
* Those with a diagnosis of other sleep disorders besides insomnia (narcolepsy, restless legs, sleep apnea, etc.)
* People who are allergic to probiotic products
* Pregnant or breastfeeding
* Alcohol, tobacco and coffee addicts
* Have carried out long-distance travel or work across time zones in the past month and the next two months
* Those who have participated in other interventional clinical studies in the past three months
* Those who are judged by the moderator to be unsuitable to participate in the research

Primary outcomes:
measure: Pittsburgh sleep quality index, PSQI
timeFrame: From baseline to 8 weeks assessed
measure: Insomnia severity index, ISI
timeFrame: From baseline to 8 weeks assessed
Secondary outcomes:
measure: Total sleep time
timeFrame: From one week before baseline to 8 weeks assessed
measure: Change in Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: From baseline to 8 weeks assessed
measure: Change in Depression Score Patient Health Questionnaire (PHQ-9)
timeFrame: From baseline to 8 weeks assessed
measure: Change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16
timeFrame: From baseline to 8 weeks assessed
measure: Change in Visual Analogue Scale-GI (VAS-GI)
timeFrame: From baseline to 8 weeks assessed
measure: Patient Global Impression scales of Improvement rated by patient（PGI-C）
timeFrame: From baseline to 8 weeks assessed
measure: Change in Melatonin in both blood and saliva
timeFrame: From baseline to 8 weeks assessed
measure: Change in Cortisol in both blood and saliva
timeFrame: From baseline to 8 weeks assessed
measure: Change in Total Antioxidant Capacity , TAC
timeFrame: From baseline to 8 weeks assessed
measure: Change in GABA in both blood and saliva
timeFrame: From baseline to 8 weeks assessed
measure: Change in Serotonin in both blood and saliva
timeFrame: From baseline to 8 weeks assessed
measure: Change in Orexin in both blood and saliva
timeFrame: From baseline to 8 weeks assessed
measure: Change in 6 sulfatoxymelatonin in urine
timeFrame: From baseline to 8 weeks assessed
measure: Change in Norepinephrine in both blood and urine
timeFrame: From baseline to 8 weeks assessed
measure: Changes in Interleukin-6 (IL-6) in saliva
timeFrame: From baseline to 8 weeks assessed
measure: Change in Gut microbiome
timeFrame: From baseline to 8 weeks assessed
measure: Sleep quality
timeFrame: From baseline to 8 weeks assessed
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Graduate Institute of Sports Science, National Taiwan Sport University
Study officials:
References: