Probiotics for improving sleep quality
Evaluating the Potential of Probiotic Supplementation Sleep Quality
This study is testing if taking a specific probiotic can help adults aged 20 to 60 sleep better over eight weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | National Taiwan Sport University Academic / other |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT06486064 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of using probiotics to enhance sleep quality in adults aged 20 to 60. Participants will be divided into two groups, receiving either heat-treated Limosilactobacillus fermentum or a placebo for eight weeks. The study will assess various indicators of sleep quality through blood, urine, saliva samples, and questionnaires. Previous animal studies have shown promising results for the probiotic strains being tested, suggesting potential benefits for human sleep improvement.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 60 with sleep quality issues as indicated by a Pittsburgh Sleep Quality Scale score of 5 or higher.
Not a fit: Patients with other sleep disorders, serious medical conditions, or those currently using medications that affect sleep may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a novel, non-pharmacological approach to improving sleep quality for individuals suffering from sleep disorders.
How similar studies have performed: While previous animal studies have shown success with similar probiotic approaches, this specific human study is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taoyuan
- Graduate Institute of Sports Science, National Taiwan Sport University — Taoyuan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chi-Chang Huang, PhD
- Email: john5523@ntsu.edu.tw
- Phone: : +886-3-3283201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.