Using bacterial lysate to prevent respiratory infections in older nursing home residents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy of OM 85, a bacterial lysate, in reducing the incidence of lower respiratory tract infections among older adults living in nursing homes. Participants aged 75 and older, who have experienced at least two respiratory infections in the past year, will be randomly assigned to receive either the bacterial lysate or a placebo. The study aims to determine if this immunostimulating treatment can enhance the immune response and lower infection rates in this vulnerable population. The research is particularly focused on older individuals who may have unique health challenges due to age-related immune decline and multiple chronic conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 75 years or older
* At least 2 RTIs in the year prior to enrollment
* Patients must have been residing in nursing homes for at least 6 months and have an estimated length of stay in nursing homes of at least 6 months by their treating physician.
* Signed informed consent. If participants are unable to provide informed consent due to cognitive impairment, consent will be provided by a legally recognized representative or trustee of the patient (pursuant to Article 4 of Law No. 219 of December 22, 2017).
* Have a life expectancy of at least one year in the judgment of their treating physician.

Exclusion Criteria:

* Patients with known allergy or previous intolerance to any component (including the excipient) of the study drug
* Patients with active neoplasia and prognosis of less than one year
* Patients with previous organ transplantation
* Patients treated with prohibited drugs (see Table 1) in the 3 months prior to the start of the study
* Patients who have taken bacterial lysates in the 6 months prior to enrollment or are currently using them
* Patients regularly treated with oral corticosteroids
* Patients unable to follow instructions and unreliable patients (including patients with alcoholism or patients unwilling to give informed consent or comply with protocol requirements)
* Patients with any other clinical condition that, in the opinion of the investigator, would not allow completion of the protocol and safe administration of the study drugs

Where it's running

• Fondazione Policlinico Campus Bio-Medico
  Roma, Rm, Italy Recruiting

Study contacts

• Study coordinator: Silvia Travaglini, MD
• Email: silvia.travaglini@unicampus.it
• Phone: +39 06 22541

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Impact of a climate-resilient WASH package in Karamoja schools

  This study tests a climate-resilient water, sanitation and hygiene package in severely water-insecure primary schools in Karamoja to see if it reduces diarrhea and respiratory infections and improves attendance, especially among girls.

  Recruiting Unicef · Moroto · NCT07823231

• Clinical Multimodal Surveillance of Respiratory Pathogens

  This nationwide study tests a hospital-based system to track respiratory pathogens in patients with respiratory symptoms and to use samples collected during care to spot trends and support prevention efforts.

  Recruiting at 31 sites Huashan Hospital · Beijing, Beijing Municipality and 30 other locations · NCT07694648

• Virological Monitoring of Seasonal Respiratory Infections in France

  This project tests how often common respiratory viruses show up in patients seen by primary care doctors in metropolitan France during the fall and winter.

  Recruiting Institut National de la Santé Et de la Recherche Médicale, France · Paris · NCT07599449

• Prevention with PMBL for recurrent RTIs in kids

  This study tests whether PMBL sublingual tablets can help prevent recurrent respiratory tract infections in children aged 3–12 compared to a placebo.

  Recruiting at 9 sites Phase 4 Lallemand Pharma AG · Bialystok and 9 other locations · NCT07578012

• Hormone replacement therapy and respiratory infection risk in postmenopausal women

  This project tests whether hormone replacement therapy changes the chance and severity of respiratory infections in postmenopausal women who wear a smartwatch for six months.

  Recruiting Insel Gruppe AG, University Hospital Bern · Bern · NCT07292857

• Respiratory infections in newborns and children up to five years

  This project will follow newborns in Colombia and Panamá through age five to see how often respiratory infections happen, which germs cause them, and how those infections affect long-term lung health.

  Recruiting at 2 sites Centro de Estudios en Infectogía Pediatrica · Cali, Valle del Cauca Department and 1 other locations · NCT07249996

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.