NCT06361368

Efficacy Assessment of Probiotics in Improving Sleep Indices

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: National Yang Ming Chiao Tung University · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To determine whether PS150 (1) reduces insomnia symptoms, (2) improves sleep quality, (3) adjusts autonomic nervous system functioning, (4) reduces the severity of anxiety and depressive symptoms, and (5) adjusts microbiome and endocrine functions.

Detailed description

One-hundred-forty participants with self-reported insomnia (PSQI≥ 7 \& 22 \> ISI ≥ 12) aged between 20 and 60 years old are estimated to be recruited and randomly assigned to two arms, the PS150 group and the placebo group, under the double-blinded trial. Participants take one capsule of probiotics or placebo after dinner for 30 days. Study measures include polysomnography (PSG), subjective sleep, depressive, and anxiety questionnaires, sleep diary, fecal sampling, saliva testing, and urine testing.

Conditions

• Insomnia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PS150	Participants took one capsule with PS150 after dinner for 30 days.
DIETARY_SUPPLEMENT	Placebo	Participants took one capsule with placebo after dinner for 30 days.

Timeline

• Start date: 2024-04-11
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-04-11
• Last updated: 2024-05-13

Locations

1 site across 1 country: Taiwan