Clinical Research Directory

Chlorhexidine and/or Metronidazole Plus FB301 Pre-treatment Trial

The goal of this study is to evaluate how treatment with FB301 affects the balance of vaginal bacteria in women (aged 18-45) with bacterial vaginosis after pre-treatment with either a vaginal antiseptic wash (chlorhexidine), an oral antibiotic (metronidazole), or both. The main question it aims to answer is: Does treatment with FB301, with or without pre-treatment using a vaginal antiseptic (chlorhexidine) or an oral antibiotic (metronidazole), change the balance of vaginal bacteria, measured by the proportion of two key bacteria (Lactobacillus crispatus and Lactobacillus jensenii), between the start of treatment and follow-up visits over the next 10 weeks? Researchers will compare participants randomly assigned to 4 different groups: * Group 1 will receive FB301for 15 days with the antibiotic (metronidazole) for the first seven days. In the next menstrual cycle, they will receive just FB301 for an additional 15-days. * Group 2 will receive FB301for 15 days. On the first day only, they will first undergo a vaginal cleanse with chlorhexidine (antiseptic solution). In the next menstrual cycle, they will receive just FB301 for an additional 15-days. * Group 3 will receive FB301for 15 days with the antibiotic (metronidazole) for the first seven days. On the first day only, they will first undergo a vaginal cleanse with chlorhexidine (antiseptic solution). In the next menstrual cycle, they will receive FB301 for an additional 15-days following a vaginal cleanse with chlorhexidine (antiseptic solution) on the first day only. * Group 4 will receive just FB301for 15 days. In the next menstrual cycle, they will receive just FB301 for an additional 15-days. Participants will: * Attend the study centre for up to 6 visits * Provide vaginal swab samples at up to 6 visits * Provide vaginal secretion samples using a menstrual disc at up to 4 visits * Have blood samples taken at up to 6 visits * Receive the study treatments for the randomly assigned group over two consecutive menstrual cycles.

An Open Single-armed Investigation to Evaluate the Safety of pHyph Following a Prolonged Treatment Duration in Adult Women With Bacterial Vaginosis

1. Rationale Bacterial vaginosis (BV) is caused by an overgrowth of bacteria and affects most women at some point. The infections can cause foul-smelling discharge and sometimes itching and burning. There are already some approved medications for the treatment of BV. They are not always effective, which means that the infection often returns. Many of these treatments contain antibiotics. In this study, a medical device will be evaluated, a vaginal tablet called pHyph. pHyph contains a substance that occurs naturally in the body, Glucono-delta-lactone, which is part of the process when the body handles sugar. It is also an approved food additive. In pHyph, Glucono-delta-lactone restores the acidity of the vagina to normal. In a slightly acidic environment, the bacteria that cause bacterial vaginosis do not thrive, but instead the lactobacilli that are found in a normal vaginal bacterial flora are favored. 2. Aim Primary aim: To evaluate the safety after 12 days of treatment with pHyph in patients with BV Secondary aims: 1. To investigate the difference in the frequency of vaginal dysbiosis after daily treatment for 6 days with pHyph compared to longer daily treatment. 2. To investigate changes in different Lactobacillus species after daily treatment for 6 days with pHyph compared to longer daily treatment. 3. To investigate the difference in clinical efficacy after daily treatment for 6 days with pHyph compared to longer daily treatment. 4. To investigate the relief of the symptom of "fishy odor" after daily treatment for 6 days with pHyph compared to longer daily treatment Exploratory aims: To evaluate vaginal microbiome data after different treatment durations in patients with BV 4. Primary outcome measure To assess the safety and well-tolerated nature of the treatment for patients receiving treatment for a total of 12 days: 1. By monitoring and recording any adverse events that occur during the treatment period, from the first visit to the fourth visit. 2. By assessing for signs of redness, swelling or irritation of the vaginal mucosa using a rating scale from 0 to 3, at days 0, 7, 14 and 25. 5\. Secondary outcome measure The study will compare changes during and after treatment at different time points (days 0, 7, 10, 14 and 25). Among other things, the following are being looked at: * Presence of bacterial imbalance in the vagina * Amount of different beneficial Lactobacillus bacteria * Proportion of patients who recover from symptoms such as foul-smelling or abnormal discharge * Change in vaginal pH and possible presence of vaginal yeast * How easy and user-friendly the treatment is perceived according to patients' responses in an app Exploratory outcome measure To further evaluate vaginal microbiome data after different treatment lengths in patients with bacterial vaginosis (BV). 6\. Study design 32 women with BV are planning to be included in the study. The aim is to evaluate the safety after 12 days of treatment (days 0-5 and days 7-12) with pHyph in patients with BV. 7\. Study population The study will include women who have had their period but have not yet reached menopause, are 18 years of age or older and are seeking treatment, directly at a clinic or via advertising, for symptoms of BV, such as foul-smelling or abnormal discharge. The diagnosis of BV is made according to the Amsel criteria, defined as having at least three of the following criteria: thin whitish-yellow discharge, special cells visible under a microscope, a vaginal pH value higher than 4.5, and a distinct fishy odor when a basic substance is added (this symptom must be present). Women with signs of other vaginal infections will not be able to participate in the study. 8\. Interventions The study includes four clinic visits over a period of approximately 25 days. All participants receive active treatment with pHyph vaginal tablets, which are inserted vaginally at home in the evening with a CE marked applicator. Exact instructions are given at the first visit. At the four clinic visits, which are made on days 0, 7, 14 and 25, a gynecological examination is performed and samples are taken. Between visits, participants answer questions about BV symptoms and treatment via a mobile app. * Visit 1 (Inclusion visit): with information, consent and pregnancy test. A gynecological examination and a sample for BV control are performed. The participant is given an applicator and tablets for 6 days of treatment to use at home every evening. * Visit 2 (Day 7): A new gynecological examination and a sample for BV control. The participant is given an additional 6 days of tablets. A sample for BV control is taken at home on Day 10. * Visit 3 (Day 14): A new gynecological examination and a sample for BV control and questions about the ease of use of the product. * Visit 4 (Day 25): Follow-up visit with a new gynecological examination, sample for BV control, pregnancy test and questions about health and menstruation.

Evaluation of the Medical Device Vagitab - T as Adjuvant Therapy in Patients With Bacterial Vaginosis.

This clinical trial is looking at how well and safely the vaginal administration of Vagitab-T works . Vagitab-T is already on the market in several countries in Europe as a medical device. The main goals of this trial are to see if the recurrence rate of bacterial vaginosis goes down during the study, if it helps balance the altered vaginal flora during antibiotic treatment, if it improves vaginal secretions, and if vaginal microflora return to normal. We'll also ask the participants about their quality of life and whether they think the treatment is safe. All 30 women will get the same treatment, and there's no comparison group. They'll be treated with Vagitab-T vaginal tablets for three monthly cycles. Also, metronidazole will be taken at the start of the study for seven days. Participants will sign an informed written consent and we'll visit them at the start (day 0) and end (day 90) of the study. In addition, we'll call them during each of the three cycles of treatment.

Probiotic Efficacy in Postmenopausal Women with Bacterial Vaginosis

This study is a double-blind, randomized, controlled trial (RCT) aimed at evaluating the effects of Lactobacillus sp. probiotic administration on the vaginal microbiota changes in postmenopausal women with bacterial vaginosis and how its affect to immunology profile. Postmenopausal women diagnosed with bacterial vaginosis will be recruited as subjects as long as collected period in this study. All patients will receive Metronidazole antibiotic treatment then blind-randomly be divided into two groups: the treatment group, receiving Floragyn® probiotic tablets (Lapi, Indonesia), and the placebo group, receiving Cal 95® (Lapi, Indonesia). As a control, postmenopausal women without bacterial vaginosis will also be included and receive Floragyn® probiotic tablets only.