Miriam Dellino1,2, Eliano Cascardi3,4, Antonio Simone Laganà5, Giovanni Di Vagno6, Antonio Malvasi7, Rosanna Zaccaro6, Katia Maggipinto6, Gerardo Cazzato8, Salvatore Scacco9, Raffaele Tinelli10, Alessandro De Luca7, Marina Vinciguerra6, Vera Loizzi11, Antonella Daniele12, Ettore Cicinelli7, Carmine Carriero7, Chiara Antonia Genco13, Gennaro Cormio11, Vincenzo Pinto7. 1. Department of Biomedical Sciences and Human Oncology, Policlinic of Bari, University of Bari, Piazza Aldo Moro, 70100, Bari, Italy. miriamdellino@hotmail.it. 2. Clinic of Obstetrics and Gynecology, "San Paolo" Hospital, ASL Bari, Bari, Italy. miriamdellino@hotmail.it. 3. Department of Medical Sciences, University of Turin, Turin, Italy. 4. Pathology Unit, FPO-IRCCS Candiolo Cancer Institute, Candiolo, Italy. 5. Unit of Gynecologic Oncology, ARNAS "Civico-Di Cristina-Benfratelli", Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, 90127, Palermo, Italy. 6. Clinic of Obstetrics and Gynecology, "San Paolo" Hospital, ASL Bari, Bari, Italy. 7. Department of Biomedical Sciences and Human Oncology, Policlinic of Bari, University of Bari, Piazza Aldo Moro, 70100, Bari, Italy. 8. Department of Emergency and Organ Transplantation, Pathology Section, University of Bari "Aldo Moro", Piazza Giulio Cesare 11, 70124, Bari, Italy. 9. Department of Basic Medical Sciences and Neurosciences, University of Bari "Aldo Moro", Piazza Giulio Cesare 11, 70124, Bari, Italy. 10. Department of Obstetrics and Gynecology, "Valle d'Itria" Hospital, Martina Franca, Italy. 11. Gynecologic Oncology Unit, IRCCS Istituto Tumori Giovanni Paolo II, Department of Interdisciplinary Medicine (DIM), University of Bari "Aldo Moro", 70121, Bari, Italy. 12. Institutional BioBank, Experimental Oncology and Biobank Management Unit, IRCCS Istituto Tumori Giovanni Paolo II, Bari, Italy. 13. Departmental of Cervical-Carcinoma Screening, ASL Bari, 70121, Bari, Italy.
Abstract
BACKGROUND: Recent studies have shown the importance of the microbiota in women's health. Indeed, the persistence of Human Papilloma Virus (HPV)-related lesions in patients with dysbiosis can be the antechamber to cervical cancer. The aim of this study was to evaluate whether long term administration of oral Lactobacillus crispatus can restore eubiosis in women with HPV infections and hence achieve viral clearance. METHODS: In total, 160 women affected by HPV infections were enrolled at the Department of Gynecological Obstetrics of "San Paolo" Hospital, Italy between February 2021 and February 2022. The women were randomly assigned to two groups, one in treatment with oral Lactobacillus crispatus M247 (group 1, n = 80) versus the control group, that hence only in follow-up (Group 2, n = 80). RESULTS: After a median follow-up of 12 months (range 10-30 months), the likelihood of resolving HPV-related cytological anomalies was higher in patients in treatment with the long term oral probiotic (group 1) versus the group that perfom only follow-up (group 2) (60.5% vs. 41.3%, p = 0.05). Total HPV clearance was shown in 9.3% of patients undergoing only follow-up compared to 15.3% of patients in the group taking long term oral Lactobacillus crispatus M247 (p = 0.34). However, the percentage of HPV-negative patients, assessed with the HPV-DNA test, documented at the end of the study period was not significantly different from the control group. CONCLUSIONS: Despite the limitations of our analysis, we found a higher percentage of clearance of PAP-smear abnormalities in patients who took long term oral Lactobacillus crispatus M247 than in the control group. Larger studies are warranted, but we believe that future research should be aimed in this direction. Trial registration This study is retrospectively registered.
BACKGROUND: Recent studies have shown the importance of the microbiota in women's health. Indeed, the persistence of Human Papilloma Virus (HPV)-related lesions in patients with dysbiosis can be the antechamber to cervical cancer. The aim of this study was to evaluate whether long term administration of oral Lactobacillus crispatus can restore eubiosis in women with HPV infections and hence achieve viral clearance. METHODS: In total, 160 women affected by HPV infections were enrolled at the Department of Gynecological Obstetrics of "San Paolo" Hospital, Italy between February 2021 and February 2022. The women were randomly assigned to two groups, one in treatment with oral Lactobacillus crispatus M247 (group 1, n = 80) versus the control group, that hence only in follow-up (Group 2, n = 80). RESULTS: After a median follow-up of 12 months (range 10-30 months), the likelihood of resolving HPV-related cytological anomalies was higher in patients in treatment with the long term oral probiotic (group 1) versus the group that perfom only follow-up (group 2) (60.5% vs. 41.3%, p = 0.05). Total HPV clearance was shown in 9.3% of patients undergoing only follow-up compared to 15.3% of patients in the group taking long term oral Lactobacillus crispatus M247 (p = 0.34). However, the percentage of HPV-negative patients, assessed with the HPV-DNA test, documented at the end of the study period was not significantly different from the control group. CONCLUSIONS: Despite the limitations of our analysis, we found a higher percentage of clearance of PAP-smear abnormalities in patients who took long term oral Lactobacillus crispatus M247 than in the control group. Larger studies are warranted, but we believe that future research should be aimed in this direction. Trial registration This study is retrospectively registered.
Authors: A Aroutcheva; D Gariti; M Simon; S Shott; J Faro; J A Simoes; A Gurguis; S Faro Journal: Am J Obstet Gynecol Date: 2001-08 Impact factor: 8.661
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