Background : Bacterial vaginosis (BV) is the most com-mon cause of vaginal discomfort in women. It is charac-terised by abnormal vaginal microbiota with a depletion of lactobacilli and predominance of anaerobic microor-ganisms, mainly Gardnerella vaginalis and Atopobium vaginae. Although antibiotics represent an effective ther-apeutic option in the short-term, recurrent infections still remain a serious problem.   
Objectives: This study aimed to characterize the bacterial biota in women affected by bacterial vaginosis (BV) and evaluate the effect of combined orally administered lac-toferrin and antibiotic treatment (Metronidazole) versus placebo and antibiotic treatment (Metronidazole) on the vaginal bacterial biota.       
Methods: This double-blind randomized controlled clin-ical trial was conducted at the Obstetrics and Gynecology Department, Faculty of Medicine, Ain Shams University Maternity Hospitals from December 2021 to December 2023 and included Sixty women diagnosed with BV and randomly divided into two groups: Group A (study group) who received 100 mg of oral lactoferrin plus Metronida-zole, and Group B (control group) who received a pla-cebo plus Metronidazole. After excluding seven partici-pants for various reasons, 27 women in Group A and 26 in Group B completed the study.   
Results: Both treatment methods were effective for bac-terial vaginosis (BV). However, the lactoferrin group showed a significantly greater improvement in clinical signs and symptoms compared to the placebo group after 10 days of treatment. Only 2 participants (7.4%) in the lactoferrin group had vaginal discharge, whereas 8 par-ticipants (30.8%) in the placebo group did (p<0.05). The cure rate was 85.2% in the lactoferrin group compared to 69.2% in the placebo group, and the recurrence rate was 14.8% in the lactoferrin group versus 30.8% in the place-bo group. There were no significant differences between the groups in terms of age, BMI, contraceptive method, history of recurrent BV, sexual activity frequency, base-line clinical signs, symptoms, and vaginal discharge sam-ples.
Conclusions: In conclusion, this study eval-uated the effectiveness of oral lactoferrin supplementation combined with antibiot-ic treatment for treating bacterial vaginosis compared to standard care. The interven-tion significantly improved BV symptoms, including vaginal discharge, clue cell pres-ence, and fishy odour. However, the differ-ences between the intervention and standard care groups were statistically insignificant.  We are aware that no firm conclusions can be drawn about the efficacy of oral lactofer-rin supplementation combined with antibiot-ic treatment for treating bacterial vaginosis compared to standard care from the results derived from such a small-sized study.