Evaluating the Potential of Probiotic Supplementation Sleep Quality

NCT ID: NCT06486064

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2024-12-30

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.

Conditions

Sleep Disorder; Anxiety; Depression; Stress; Probiotics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

probiotics

heat-treated Limosilactobacillus fermentum PS150

Group Type: EXPERIMENTAL

heat-treated Limosilactobacillus fermentum

Intervention Type: DIETARY_SUPPLEMENT

one capsule daily for 8 weeks

placebo

microcrystalline cellulose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

one capsule daily for 8 weeks

Interventions

heat-treated Limosilactobacillus fermentum

one capsule daily for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

one capsule daily for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

HT-PS150

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bened Biomedical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Chi-Chang Huang

OTHER

Sponsor Role: lead

Responsible Party

Chi-Chang Huang

Dean of Research and Development Office

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Graduate Institute of Sports Science, National Taiwan Sport University

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

B032

Identifier Type: -

Identifier Source: org_study_id