Comparison of the effect of oral metronidazole and vaginal probiotics on the vaginal microbial flora in women with bacterial vaginosis and evaluation of treatment failure

Comparison of the effect of oral metronidazole and vaginal probiotics on the vaginal microbial flora in women with bacterial vaginosis

This study is a randomized trial that is phase 2-3 of the study and block randomization method has been used for randomization

This study is a randomized clinical trial study in which women with a diagnosis of bacterial vaginosis are divided into two equal groups of metronidazole and probiotics and then compared in terms of effectiveness of the two treatments.

Inclusion criteria: 1- Women with a diagnosis of bacterial vaginosis , 2- Age between 18 and 45 years , 3- No pregnancy or HIV positive , 4- No history of known medical conditions such as epilepsy, diabetes, hypertension and heart and gastrointestinal problems Non-consumption of alcohol and anticoagulants such as coumadin (warfarin), immunosuppressants, vaginal medications, 6- having an IUD Conditions of non-entry : 1- Dissatisfaction with continued cooperation 2- Having serious drug side effects 3- Do not take nutritional supplements 4- Existence of other non-bacterial infections of the vagina 5-Taking antibiotics

Metronidazole group: Oral treatment with 500 mg metronidazole twice daily for 7 days. Probiotic group: Probiotic vaginal capsules (lactobacillus acidophilus, lactobacillus plantarum, lactobacillus rhamnosos, lactobacillus gasseri) are taken once a day for 14 days.

Amsel positive criteria 2- Nugent score 3-The pH of vaginal discharge 4- Existence of homogeneous dilute white-gray discharge 5- Amine test The 6- presence of Clue cells in the vaginal discharge slide

Participants are assigned to two intervention and control groups, respectively, based on the randomization sequence that will be generated beforehand. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate samples. Thus, using block numerical random number generation software, a randomization sequence proportional to the sample size required for the two groups will be generated. Initially, all cases in which the two letters A and B can be arranged in blocks of 8 are produced. A block is then randomly selected from the blocks and the layout pattern in that block will be used to assign participants. This block will then be placed in the main container and another block will be selected again. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups. In fact, the researcher will not be able to predict which group the next person will be in.

After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study.

Access will be from 2023/4/20 to 2026/4/20 for 3 years.

University researchers

If there are any further questions

Dr. Nazila Najdi

Letter writing should be done with professors and universities.