Evaluating the Potential of Probiotic Supplementation Sleep Quality

Chi-Chang Huang

Status: Completed

Conditions: Sleep Disorder; Depression; Probiotics; Anxiety; Stress

Treatments: Dietary Supplement: Placebo; Dietary Supplement: heat-treated Limosilactobacillus fermentum

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06486064

B032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups, including a placebo group

probiotics

Experimental group

Description:

heat-treated Limosilactobacillus fermentum PS150

Treatment:

Dietary Supplement: heat-treated Limosilactobacillus fermentum

placebo

Placebo Comparator group

Description:

microcrystalline cellulose

Treatment:

Dietary Supplement: Placebo