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dc.contributor.author
de Gregorio, Priscilla Romina
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Maldonado, Natalia Cecilia
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Vera Pingitore, Esteban
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Leccese Terraf, Maria Cecilia
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Juárez Tomás, María Silvina
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Silva de Ruiz, C.
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Santos, V.
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Wiese, B.
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Bru Chauve, Elena Magdalena
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Paiz, M. C.
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Reina, M. F.
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Schujman, D. E.
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Nader, Maria Elena Fatima
dc.date.available
2020-05-28T13:25:02Z
dc.date.issued
2020-02
dc.identifier.citation
de Gregorio, Priscilla Romina; Maldonado, Natalia Cecilia; Vera Pingitore, Esteban; Leccese Terraf, Maria Cecilia; Juárez Tomás, María Silvina; et al.; Intravaginal administration of gelatine capsules containing freeze-dried autochthonous lactobacilli: a double-blind, randomised clinical trial of safety; Wageningen Academic; Beneficial Microbes; 11; 1; 2-2020; 5-17
dc.identifier.issn
1876-2883
dc.identifier.uri
http://hdl.handle.net/11336/106092
dc.description.abstract
Vaginal lactobacilli (LAB) in probiotic formulas constitute a promising alternative for microbiome reconstitution and for the prevention and treatment of urogenital infections. A double-blind, randomised clinical trial was conducted to assess the safety of LAB-gelatine capsules vaginally administered to healthy sexually active women. Participants were randomised into three groups: intervention A: Lactobacillus reuteri CRL1324, L. gasseri CRL1263 and CRL1307; intervention B: L. rhamnosus CRL1332, L. gasseri CRL1256 and CRL1320; and intervention C: placebo. In a survey and clinical evaluation, participants received a blister with 7 capsules to be administered 1 per day. A second sampling and a new survey were conducted 3-10 days after completing application. Colposcopy was performed to assess adverse effects on vaginal-cervical mucosa. Vaginal swabs were taken for Gram staining to determine the Nugent score, and obtainment of viable-cell cultures to quantify cultivable lactic acid bacteria and pathogens. The main outcomes evaluated were overall satisfaction and secondary effects, including discomfort, urogenital infection, inflammatory response or other symptoms. No significant differences were found in Nugent score or in leukocyte numbers in vaginal samples either before or after the three interventions. However, a tendency to decrease in both the Nugent score and in leukocyte numbers was observed after interventions A and B, though not after C. A significant increase in cultivable lactobacilli was determined after LAB interventions. No severe adverse events were detected. LAB-containing capsules were well tolerated by subjects, so they could be proposed as an adequate alternative to restore vaginal lactobacilli in sexually active women.
dc.format
application/pdf
dc.language.iso
eng
dc.publisher
Wageningen Academic
dc.rights
info:eu-repo/semantics/restrictedAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.subject
PHASE I ASSAY
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PROBIOTICS
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LACTOBACILLI
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Otras Biotecnologías de la Salud
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Biotecnología de la Salud
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CIENCIAS MÉDICAS Y DE LA SALUD
dc.title
Intravaginal administration of gelatine capsules containing freeze-dried autochthonous lactobacilli: a double-blind, randomised clinical trial of safety
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2020-05-19T18:50:55Z
dc.journal.volume
11
dc.journal.number
1
dc.journal.pagination
5-17
dc.journal.pais
Países Bajos
dc.journal.ciudad
Amsterdan
dc.description.fil
Fil: de Gregorio, Priscilla Romina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tucumán. Centro de Referencia para Lactobacilos; Argentina
dc.description.fil
Fil: Maldonado, Natalia Cecilia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tucumán. Centro de Referencia para Lactobacilos; Argentina
dc.description.fil
Fil: Vera Pingitore, Esteban. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tucumán. Centro de Referencia para Lactobacilos; Argentina
dc.description.fil
Fil: Leccese Terraf, Maria Cecilia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tucumán. Centro de Referencia para Lactobacilos; Argentina
dc.description.fil
Fil: Juárez Tomás, María Silvina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tucumán. Centro de Referencia para Lactobacilos; Argentina
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Fil: Silva de Ruiz, C.. Universidad Nacional de Tucumán. Facultad de Bioquímica, Química y Farmacia; Argentina
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Fil: Santos, V.. Universidad Nacional de Tucumán. Facultad de Bioquímica, Química y Farmacia; Argentina
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Fil: Wiese, B.. Medizinische Hochschule Hannover; Alemania
dc.description.fil
Fil: Bru Chauve, Elena Magdalena. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tucumán. Centro de Referencia para Lactobacilos; Argentina
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Fil: Paiz, M. C.. Hospital de Clínicas Nicolás Avellaneda; Argentina
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Fil: Reina, M. F.. Hospital de Clínicas Nicolás Avellaneda; Argentina
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Fil: Schujman, D. E.. Hospital de Clínicas Nicolás Avellaneda; Argentina
dc.description.fil
Fil: Nader, Maria Elena Fatima. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tucumán. Centro de Referencia para Lactobacilos; Argentina
dc.journal.title
Beneficial Microbes
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/https://www.wageningenacademic.com/doi/10.3920/BM2019.0081
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/https://doi.org/10.3920/BM2019.0081