Evaluating the Potential of Probiotic Supplementation Sleep Quality

NCT06486064 | Completed

• 1 other identifier: B032
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder; Anxiety; Depression; Stress; Probiotics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Total sleep time

  From one week before baseline to 8 weeks assessed

• Change in Generalised Anxiety Disorder Assessment (GAD-7)

  From baseline to 8 weeks assessed

• Change in Depression Score Patient Health Questionnaire (PHQ-9)

  From baseline to 8 weeks assessed

• Change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16

  From baseline to 8 weeks assessed

• Change in Visual Analogue Scale-GI (VAS-GI)

  From baseline to 8 weeks assessed

Study Arms (2)

probiotics

EXPERIMENTAL

heat-treated Limosilactobacillus fermentum PS150

Dietary Supplement: heat-treated Limosilactobacillus fermentum

placebo

PLACEBO COMPARATOR

microcrystalline cellulose

Dietary Supplement: Placebo

Interventions

heat-treated Limosilactobacillus fermentum DIETARY_SUPPLEMENT

one capsule daily for 8 weeks

Also known as: HT-PS150

probiotics

Placebo DIETARY_SUPPLEMENT

one capsule daily for 8 weeks

placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chi-Chang Huang: lead
• Bened Biomedical Co., Ltd.: collaborator

Study Sites (1)

Graduate Institute of Sports Science, National Taiwan Sport University

Taoyuan District, 33301, Taiwan

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dean of Research and Development Office

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 3, 2024
• Study Start: August 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

TW (1)