NCT06486064

Evaluating the Potential of Probiotic Supplementation Sleep Quality

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Chi-Chang Huang · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	heat-treated Limosilactobacillus fermentum	one capsule daily for 8 weeks
DIETARY_SUPPLEMENT	Placebo	one capsule daily for 8 weeks

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-10-30
• Completion: 2024-12-30
• First posted: 2024-07-03
• Last updated: 2025-07-20

Locations

1 site across 1 country: Taiwan