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The Effect and Mechanism of Probiotics on Sleep Disorders in Hemodialysis Patients

The Effect and Mechanism of Probiotics on Sleep Disorders in Maintenance Hemodialysis Patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016358
Enrollment
Unknown
Registered
2018-05-28
Start date
2018-06-15
Completion date
Unknown
Last updated
2018-06-05

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

Conditions

sleep disorder

Interventions

Experimental group:Bifidobacterium triple live enteric-coated capsules, 0.21g each morning and evening, a month is a course of treatment
Control group:Routine treatment

Sponsors

Huai'an Hospital Affiliated to Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) patients with chronic renal failure who had received stable hemodialysis for more than 3 months before being enrolled; 2) aged more than 18 years male and female Chinese citizens; 3) no antibiotics were used in the four weeks before the start of the experiment; no probiotics were used within three weeks; 4) no special diet or regular use of bev????????????,0.21g ?????,1?????erages and preparations containing probiotics; 5) conforms to the diagnostic criteria of insomnia in the third edition of international classification of sleep disorders, and insomnia occurs after dialysis treatment; 6) Pittsburgh's sleep quality score is equal or more than to 7 points; 7) informed consent of the patient and signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Pittsburgh's sleep quality score is less than 7 points; 2) end-stage heart failure (NYHAI IV); 3) a serious history of liver disease; 4) ALT or AST is 2 times higher than the upper limit of the normal value; 5) suffering from malignant tumor; the tumor was not controlled, in the active period, the expected survival time was less than 1 years; 6) was treated with immunosuppressive agents or other biological agents within 3 months; 7) taking part in the test within 3 months; 8) a person with a history of mental illness; 9) life expectancy is less than 12 months; 10) take other drugs to improve sleep and other sleep therapists; 12) there are serious physical symptoms, such as bone pain and itchy skin; 13) severe anemia (hemoglobin < 60 micrograms / L) or fatigue caused by malnutrition (serum albumin < 30 microgram / liter).

Design outcomes

Primary

MeasureTime frame
Melatonin;

Countries

China

Contacts

Public ContactDonghui Zheng

Huai'an Hospital Affiliated to Xuzhou Medical University

zddwjj@126.com+86 13852301333

Outcome results

None listed

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