Study of Lactobacillus plantarum PS128 in improving sleep disturbance: a randomized controlled trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000031941

Enrollment

Unknown

Registered

2020-04-15

Start date

2020-06-01

Completion date

Unknown

Last updated

2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sleep disturbance

Interventions

experimental group:probiotics

placebo group:placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 20~60 years; 2. Pittsburgh Sleep Quality Index >= 10; 3. 18.5 kg/m2 <= BMI <= 24 kg/m2; 4. Normal blood pressure: systolic blood pressure (high pressure) 90-140mmHg, diastolic blood pressure (low pressure) 60-90mmHg; 5. Regular schedule; 6. Signing informed consent.

Exclusion criteria

Exclusion criteria: 1. Have taken probiotic products within two weeks (except foods such as yogurt and lactic acid bacteria drinks); 2. Have taken or are receiving antibiotics within a month; 3. Have used psychiatric or sleeping pills within two months; 4. Gastrointestinal surgery in the past year; 5. Tobacco, alcohol, caffeine and drug addicts; 6. Patients with inflammatory bowel disease, severe depression (SDS >= 73), malinant tumors or AIDS; 7. Participating in other clinical trials; 8. Other circumstances not suitable for this study.

Design outcomes

Primary

Measure	Time frame
Intestinal flora analysis;Scale assessment;Hematological oxidative stress indicators;	—

Countries

China

Contacts

Public ContactWen Hu

West China Hospital, Sichuan University

wendy_nutrition@163.com+86 18980601164

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026