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Safety and Efficacy of OM-85 BV in the Prevention of Acute Respiratory Tract Infections in elderly persons: A Randomized Controlled Trial

Safety and Efficacy of OM-85 BV in the Prevention of Acute Respiratory Tract Infections in elderly persons: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017306
Enrollment
Unknown
Registered
2018-07-23
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-07-31

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

Conditions

Acute Respiratory Tract Infections in elderly persons

Interventions

monitoring group(OM-85 group):OM-85 monitoring group will receive two courses of OM-85. The subjects will receive one capsule po, OM-85 (7 mg) per day in a month for 10 consecutive days per month for
Control group:Blank

Sponsors

the First Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Elderly peoples(=65 years of age ), each participant should have had at least three Acute Respiratory Tract Infections in the previous year.

Exclusion criteria

Exclusion criteria: active tuberculosis; hypersensitivity to any components of OM-85; subject has received an immunostimulant (including thymosin, interferon, transfer factor, BCG polysaccharide, pneumonia vaccine, and any kind of bacterial extract ) or immunosuppressive agents in last three months; severe cardiovascular disease; significant hepatic or renal insufficiency; any chronic disease which might impair the patients ability to participate in the study (i.e., active gastric or duodenal ulcer, uncontrolled diabetes mellitus, etc.); major surgical procedure in last three months or unreliable patients (non-compliance, alcoholism).

Design outcomes

Primary

MeasureTime frame
the numbers of acute respiratory tract Infection;

Countries

China

Contacts

Public ContactPing Yan

Geriatric Respiratory Disease Ward, the First Affiliated Hospital of Guangxi Medical University

yp2000cn@126.com+86 13607885541

Outcome results

None listed

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