A blinded, randomized and controlled multicenter clinical trial to assess the efficacy and safety of Leisguard ® as an immunotherapeutic treatment for healthy Leishmania infantum -seropositive dogs

Domperidone (Leisguard ®) is an immunomodulatory drug used as a preventive measure in healthy dogs. However, no studies have been published in healthy Leishmania infantum -seropositive dogs. The aim of this study was to evaluate the clinical efficacy and safety of domperidone as immunotherapy in Lei...

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Authors: Baxarias, Marta|||0000-0002-1830-4366, Donato, Giulia, Mateu, Cristina, Salichs, Marta, Homedes, Josep|||0000-0001-5440-7699, Miró, Guadalupe|||0000-0003-0981-2470, Pennisi, Maria Grazia|||0000-0002-3169-4194, Solano Gallego, Laia|||0000-0001-8479-4896
Format: article
Publication Date:2023
Country:España
Institution:Universitat Autònoma de Barcelona
Repository:Dipòsit Digital de Documents de la UAB
Language:English
OAI Identifier:oai:ddd.uab.cat:320148
Online Access:https://ddd.uab.cat/record/320148
https://dx.doi.org/urn:doi:10.1186/s13071-023-05903-0
Access Level:Open access
Keyword:Antibody
Canine
Domperidone
Interferon gamma
Leishmaniosis
PCR
Placebo
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spelling A blinded, randomized and controlled multicenter clinical trial to assess the efficacy and safety of Leisguard ® as an immunotherapeutic treatment for healthy Leishmania infantum -seropositive dogsBaxarias, Marta|||0000-0002-1830-4366Donato, GiuliaMateu, CristinaSalichs, MartaHomedes, Josep|||0000-0001-5440-7699Miró, Guadalupe|||0000-0003-0981-2470Pennisi, Maria Grazia|||0000-0002-3169-4194Solano Gallego, Laia|||0000-0001-8479-4896AntibodyCanineDomperidoneInterferon gammaLeishmaniosisPCRPlaceboDomperidone (Leisguard ®) is an immunomodulatory drug used as a preventive measure in healthy dogs. However, no studies have been published in healthy Leishmania infantum -seropositive dogs. The aim of this study was to evaluate the clinical efficacy and safety of domperidone as immunotherapy in Leishmania -seropositive healthy dogs. Sixty-seven dogs were treated with domperidone at 0.5 mg/kg and 44 dogs received placebo, once daily for 4 consecutive weeks. Monthly treatments were repeated every 4 months until the end of the 1-year follow-up period. Veterinary examinations were performed on days 0, 30, 120, 150, 240, 270 and 360. Samples of blood and urine were collected on days 0, 120, 240 and 360 for routine laboratory tests and quantitative in-house ELISA for the detection of L. infantum -specific antibodies. Furthermore, Leishmania real-time PCR and IFN-γ ELISA were performed at day 0 and the end of the study. Dogs that developed disease were withdrawn from the study and classified as sick dogs. Adverse drug reactions were reported. Thirty dogs developed disease during the follow-up period: 13/67 (19.4%) in the group treated with domperidone and 17/44 (38.6%) in the placebo-treated group (P = 0.03). Low-seropositive dogs treated with domperidone (4/40, 9.1%) were significantly less likely to develop disease compared to low-seropositive dogs treated with placebo (7/24, 29.2%; P = 0.04), while no differences were found between domperidone (9/23, 39.1%) and placebo (10/20, 50%) in medium- to high-seropositive dogs. At the end of the study, a higher proportion of Leishmania PCR-positive dogs was observed in the placebo-treated group (16/33, 48.5%) compared to the domperidone group (13/51, 25.5%; P = 0.04). Furthermore, low-seropositive dogs treated with domperidone with an increase of IFN-γ concentration presented a higher increase than those treated with placebo at the end of the study. Four dogs treated with domperidone presented self-limiting diarrhea. Healthy dogs with low L. infantum antibody levels treated with domperidone were less likely to develop disease compared to placebo-treated dogs. Furthermore, domperidone presented a good safety profile. The online version contains supplementary material available at 10.1186/s13071-023-05903-0. 22023-01-0120232023-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/320148https://dx.doi.org/urn:doi:10.1186/s13071-023-05903-0reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:3201482026-06-06T12:50:31Z
dc.title.none.fl_str_mv A blinded, randomized and controlled multicenter clinical trial to assess the efficacy and safety of Leisguard ® as an immunotherapeutic treatment for healthy Leishmania infantum -seropositive dogs
title A blinded, randomized and controlled multicenter clinical trial to assess the efficacy and safety of Leisguard ® as an immunotherapeutic treatment for healthy Leishmania infantum -seropositive dogs
spellingShingle A blinded, randomized and controlled multicenter clinical trial to assess the efficacy and safety of Leisguard ® as an immunotherapeutic treatment for healthy Leishmania infantum -seropositive dogs
Baxarias, Marta|||0000-0002-1830-4366
Antibody
Canine
Domperidone
Interferon gamma
Leishmaniosis
PCR
Placebo
title_short A blinded, randomized and controlled multicenter clinical trial to assess the efficacy and safety of Leisguard ® as an immunotherapeutic treatment for healthy Leishmania infantum -seropositive dogs
title_full A blinded, randomized and controlled multicenter clinical trial to assess the efficacy and safety of Leisguard ® as an immunotherapeutic treatment for healthy Leishmania infantum -seropositive dogs
title_fullStr A blinded, randomized and controlled multicenter clinical trial to assess the efficacy and safety of Leisguard ® as an immunotherapeutic treatment for healthy Leishmania infantum -seropositive dogs
title_full_unstemmed A blinded, randomized and controlled multicenter clinical trial to assess the efficacy and safety of Leisguard ® as an immunotherapeutic treatment for healthy Leishmania infantum -seropositive dogs
title_sort A blinded, randomized and controlled multicenter clinical trial to assess the efficacy and safety of Leisguard ® as an immunotherapeutic treatment for healthy Leishmania infantum -seropositive dogs
dc.creator.none.fl_str_mv Baxarias, Marta|||0000-0002-1830-4366
Donato, Giulia
Mateu, Cristina
Salichs, Marta
Homedes, Josep|||0000-0001-5440-7699
Miró, Guadalupe|||0000-0003-0981-2470
Pennisi, Maria Grazia|||0000-0002-3169-4194
Solano Gallego, Laia|||0000-0001-8479-4896
author Baxarias, Marta|||0000-0002-1830-4366
author_facet Baxarias, Marta|||0000-0002-1830-4366
Donato, Giulia
Mateu, Cristina
Salichs, Marta
Homedes, Josep|||0000-0001-5440-7699
Miró, Guadalupe|||0000-0003-0981-2470
Pennisi, Maria Grazia|||0000-0002-3169-4194
Solano Gallego, Laia|||0000-0001-8479-4896
author_role author
author2 Donato, Giulia
Mateu, Cristina
Salichs, Marta
Homedes, Josep|||0000-0001-5440-7699
Miró, Guadalupe|||0000-0003-0981-2470
Pennisi, Maria Grazia|||0000-0002-3169-4194
Solano Gallego, Laia|||0000-0001-8479-4896
author2_role author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Antibody
Canine
Domperidone
Interferon gamma
Leishmaniosis
PCR
Placebo
topic Antibody
Canine
Domperidone
Interferon gamma
Leishmaniosis
PCR
Placebo
description Domperidone (Leisguard ®) is an immunomodulatory drug used as a preventive measure in healthy dogs. However, no studies have been published in healthy Leishmania infantum -seropositive dogs. The aim of this study was to evaluate the clinical efficacy and safety of domperidone as immunotherapy in Leishmania -seropositive healthy dogs. Sixty-seven dogs were treated with domperidone at 0.5 mg/kg and 44 dogs received placebo, once daily for 4 consecutive weeks. Monthly treatments were repeated every 4 months until the end of the 1-year follow-up period. Veterinary examinations were performed on days 0, 30, 120, 150, 240, 270 and 360. Samples of blood and urine were collected on days 0, 120, 240 and 360 for routine laboratory tests and quantitative in-house ELISA for the detection of L. infantum -specific antibodies. Furthermore, Leishmania real-time PCR and IFN-γ ELISA were performed at day 0 and the end of the study. Dogs that developed disease were withdrawn from the study and classified as sick dogs. Adverse drug reactions were reported. Thirty dogs developed disease during the follow-up period: 13/67 (19.4%) in the group treated with domperidone and 17/44 (38.6%) in the placebo-treated group (P = 0.03). Low-seropositive dogs treated with domperidone (4/40, 9.1%) were significantly less likely to develop disease compared to low-seropositive dogs treated with placebo (7/24, 29.2%; P = 0.04), while no differences were found between domperidone (9/23, 39.1%) and placebo (10/20, 50%) in medium- to high-seropositive dogs. At the end of the study, a higher proportion of Leishmania PCR-positive dogs was observed in the placebo-treated group (16/33, 48.5%) compared to the domperidone group (13/51, 25.5%; P = 0.04). Furthermore, low-seropositive dogs treated with domperidone with an increase of IFN-γ concentration presented a higher increase than those treated with placebo at the end of the study. Four dogs treated with domperidone presented self-limiting diarrhea. Healthy dogs with low L. infantum antibody levels treated with domperidone were less likely to develop disease compared to placebo-treated dogs. Furthermore, domperidone presented a good safety profile. The online version contains supplementary material available at 10.1186/s13071-023-05903-0.
publishDate 2023
dc.date.none.fl_str_mv 2
2023-01-01
2023
2023-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/320148
https://dx.doi.org/urn:doi:10.1186/s13071-023-05903-0
url https://ddd.uab.cat/record/320148
https://dx.doi.org/urn:doi:10.1186/s13071-023-05903-0
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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