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Abstract It has been demonstrated in a number of studies that lactobacilli are responsible for maintaining a healthy vaginal environment. A number of different mechanisms, such as the production of lactic acid, the enhancement of the host’s innate immune system, and the production of antimicrobial compounds, such as target-specific bacteriocins and broad-spectrum hydrogen peroxide (H2O2), are utilized by these microorganisms in order to perform their defensive function against pathogens. It is estimated that approximately forty to fifty percent of women throughout the world are affected with bacterial vaginosis (BV), which is the most prevalent condition that is associated with an imbalance in the vaginal microbiota. Even in the event that antibiotics are effective in treating bacterial vaginosis (BV), roughly twenty-five percent of women will experience a second episode of BV within four weeks, and the long-term recurrence rate can exceed seventy percent. In addition to this, antibiotic treatment comes with a number of potential downsides. As a consequence of these circumstances, it is necessary to discover alternative kinds of medicinal drugs. It is a transferrin-family iron-binding glycoprotein that is generated and retained in distinct (secondary) neutrophil granules before being released during neutrophil activation and degranulation. Lactoferrin is a member of the transferrin family. In addition to being bacteriostatic and bactericidal, lactoferrin has the ability to protect the host from infection by binding to and limiting the quantities of iron that are required for the development of bacteria. The immunomodulation and destruction of the cytoplasmic membrane of the target cell are the mechanisms that are responsible for the antibacterial activity of lactoferrin. In addition, lactoferrin produces a synergistic effect when combined with immunoglobulin A, lysozyme, antibiotics, and other drugs, which contributes to the elimination of microorganisms. Consequently, this study was conducted and aimed to characterize the bacterial biota in women affected by BV and assess the effect of combined orally administered lactoferrin (100 mg) plus antibiotic treatment “Metronidazole” versus placebo plus antibiotic treatment “Metronidazole” on the vaginal bacterial biota. This double-blind randomized controlled clinical trial was conducted at Obstetrics and Gynecology Department, Faculty of Medicine, Ain Shams University Maternity Hospitals from December 2021 to December 2023. During this study, a total of 60 women were enrolled, after consenting each of them and divided into 2 groups, 7 women were excluded due to different causes and 27 women were included in group A and 26 in group B. group A (study group) received lactoferrin plus antibiotic treatment and group B (control group) received placebo plus antibiotic treatment. Our study revealed that both study regimens were effective in treatment of bacterial vaginosis. However, clinical signs and symptoms of vaginosis after 10 days of treatment were statistically significant improved in lactoferrin group compared with placebo; vaginal discharge 2 (7.4%) vs. 8 (30.8%). Regarding cure rate and incidence of recurrence of infection, we reported no differences between study groups; 23 (85.2%) vs. 18 (69.2%) and 4 (14.8%) vs. 8 (30.8%) respectively. In the other hand, no differences were noted between study groups regarding age, BMI, method of contraception, history of recurrent bacterial vaginosis, frequency of sexual activity, baseline clinical signs, symptoms and vaginal discharge sampling of vaginosis. In conclusion, using of lactoferrin in combination with metronidazole in treatment of bacterial vaginosis is effective and has favorable safety profile. In recommendation, lactoferrin is advised to be routinely used in treatment of bacterial vaginosis but further studies are still required to prove the efficacy of lactoferrin in prevention of recurrence of infection. Using of lactoferrin can significantly improve the vaginal bacterial flora. Lactobacillus, which was detectable in the vaginas of all patients after lactoferrin therapy, gradually became dominant. The findings from other studies suggest that administering lactoferrin to humans could help prevent refractory vaginitis, cervical inflammation, and preterm delivery. The present study can burden the knowledge and shed some light on future prospective studies with larger sample sizes and longer follow up to reassess our findings. |