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People living in NH are at higher risk of respiratory infections compared to their counterpart living in the community. Products obtained from dead bacteria ("bacterial lysate") can be used to boost immune system and may reduce the risk of respiratory infections. Very little information is available on the effect of these substances in older people. This study will evaluate the efficacy of a bacterial lysate in reducing the incidence of lower respiratory tract infections in older people living in nursing homes. The study will include a treatment arm, in which participants will received the lysate, and a control arm in which participants will received a matching placebo (i.e., a pill that has the same appearance of the lysate but does not contain the lysate itself).

开始日期2024-11-01

申办/合作机构

Università Campus Bio-Medico di Roma

[+1]

NCT06486662 / Recruiting临床1期

Safety, Tolerability and Pharmacodynamics of Single and Multiple Ascending Doses of OM-85-IN Versus Placebo in Healthy Volunteers, and Patients With Mild Allergic Asthma Using Nasal Allergen Challenge

This study will assess the safety and tolerability of OM-85-IN compared to placebo in healthy volunteers and mild asthmatic patients

开始日期2024-06-14

申办/合作机构

OM Pharma SA

NCT06345014 / Recruiting临床4期

A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase 4 Study to Evaluate the Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

This study is planned to Evaluate the Efficacy and Safety of OM-89 in Patients with Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

开始日期2023-12-20

申办/合作机构

Aju Pharm Co. Ltd.

[+1]

100 项与 OM Pharma SA 相关的临床结果

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0 项与 OM Pharma SA 相关的专利（医药）

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12

项与 OM Pharma SA 相关的文献（医药）

2024-06-01·Mucosal Immunology

The bacterial lysate OM-85 engages Toll-like receptors 2 and 4 triggering an immunomodulatory gene signature in human myeloid cells

Article

作者: Rinaldi, Andrea ; Moro, Simone G ; Guerra, Jessica ; Bolis, Marco ; Fischer, Berenice A ; Pasquali, Christian ; Baulier, Edouard ; Sallusto, Federica ; Bernasconi, Maurizio ; Ventura, Pedro M O ; Zenobi, Alessandro ; Guarda, Greta ; Buzzago, Irene ; Zaman, Guido J R ; Khameneh, Hanif J ; Cassanmagnago, Giada A

OM-85 is a bacterial lysate used in clinical practice to reduce duration and frequency of recurrent respiratory tract infections. Whereas knowledge of its regulatory effects in vivo has substantially advanced, the mechanisms of OM-85 sensing remain inadequately addressed. Here, we show that the immune response to OM-85 in the mouse is largely mediated by myeloid immune cells through Toll-like receptor (TLR) 4 in vitro and in vivo. Instead, in human immune cells, TLR2 and TLR4 orchestrate the response to OM-85, which binds to both receptors as shown by surface plasmon resonance assay. Ribonucleic acid-sequencing analyses of human monocyte-derived dendritic cells reveal that OM-85 triggers a pro-inflammatory signature and a unique gene set, which is not induced by canonical agonists of TLR2 or TLR4 and comprises tolerogenic genes. A largely overlapping TLR2/4-dependent gene signature was observed in individual subsets of primary human airway myeloid cells, highlighting the robust effects of OM-85. Collectively, our results suggest caution should be taken when relating murine studies on bacterial lysates to humans. Furthermore, our data shed light on how a standardized bacterial lysate shapes the response through TLR2 and TLR4, which are crucial for immune response, trained immunity, and tolerance.

2023-11-01·International Angiology

Enhancing identification and treatment of patients with concomitant chronic venous insufficiency and diabetes mellitus. A modified Delphi study from the CODAC (ChrOnic venous disease and Diabetes Advisory Council) group

Article

作者: Rosas-Saucedo, Juan ; VAN Rijn, Marie J ; Rabe, Eberhard ; Bouskela, Eliete ; Zingg, Daniel ; Glauser, Frederic ; Calabrese, Alessandra ; Bozkurt, Ahmet K ; Mansilha, Armando ; Gastaldi, Giacomo ; Haller, Hermann

BACKGROUNDChronic venous insufficiency (CVI) and diabetes mellitus (DM) pose significant burdens to patients and healthcare systems. While the two diseases share a number of commonalities in risk factors and pathophysiology, they are often assessed and managed separately. This can lead to a worsening of comorbidities and limitations in a patient's quality of life. This project aims to develop recommendations to enhance the identification and treatment of patients with concomitant CVI and DM.METHODSUsing a modified Delphi method, a panel of experts developed 38 Likert Scale and two multiple choice questions across six key themes. These were used to form an online survey which was disseminated through a convenience sampling approach to CVI and DM healthcare professionals across Europe, Central America, South America, and the Middle East. The threshold for consensus was set at ≥75%.RESULTSA total of 238 responses were received. 27/38 statements attained >90% agreement, nine of 38 attained between 75-90%, and two failed to meet the threshold (<75%). The awareness around the impact of the two diseases was high, but a gap was highlighted in the identification of patients with concomitant CVI and DM.CONCLUSIONSThe high level of agreement shows that healthcare professionals are aware of the gaps in identification and treatment of patients with concomitant CVI and DM, and of the need to approach this as a combined therapy area. An algorithm is proposed to help the identification of at-risk patients and to provide recommendations on the management of patients with concomitant disease.

2023-05-01·A62. B-A-C-T-E-R-I-A, FIND OUT WHAT IT MEANS TO ME

Establishment of an Isolated Perfused Lung Model for Analysis of Local Induced Immune Response of the Immuno-modulating Agent OM-85

作者: Vaslin Chessex, A. ; Cleeves, S. ; Pasquali, C. ; Abadie, C. ; Obernolte, H. ; Beneke, V. ; Schwarz, K.

100 项与 OM Pharma SA 相关的药物交易

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