Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis
- Conditions
- Bacterial Vaginosis
- Interventions
- Registration Number
- NCT01841411
- Lead Sponsor
- Minia University
- Brief Summary
N-Acetyl cysteine (NAC) is an amino acid with strong antioxidant, mucolytic and antibacterial properties, and is produced within the human body.Its effect in biofilms has been tested in several bacteria. Biofilms have recently been observed in 90% of subjects with bacterial vaginosis (BV) with Gardnerella vaginalis being the predominant species. Although a wide range of antimicrobial agents are currently available, treatment options for controlling BV are still limited. Furthermore, the number of relapses are increasing and require alternative treatments. This study is aiming to evaluate the role of NAC in treatment of BV and prevention of recurrence.
- Detailed Description
Bacterial vaginosis (BV) is the most frequent diagnosis made in women with lower genital tract symptoms. It has recently been observed that 90% of subjects with BV show the growth of bacteria in the form of biofilms,and that Gardnerella vaginalis was the predominant species. The propensity of G. vaginalis to form biofilm is clinically relevant because this form of growth allows it to tolerate higher concentrations of certain antibiotics, thus increasing the possibility of recurrent BV even after apparently curative therapy. So new treatment strategies must be used to insure complete cure and prevent recurrence. NAC is an amino acid with strong antioxidant, mucolytic and antibacterial properties, and is produced within the human body.Its effect in biofilms has been tested in several bacteria.
This study aims to test the efficacy of NAC in treatment of BV either alone or in combination with the traditionally used metronidazole. Also the effect of using NAC in prevention of recurrence of BV will be monitored.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 90
- patients complaining bacterial vaginosis and proved to have BV using standard diagnostic methods for BV
- patients with age between 20-50
- Virgins and menstruating patients.
- Recent douching or sexual intercourse.
- Use of systematic or vaginal antimicrobial therapy or any vaginal suppositories or drugs.
All patients will sign a written consent before starting the treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metronidazole + N-Acetyl cysteine Metronidazole + N-Acetyl cysteine the second patient group will use NAC sachets containing 200 mg as a vaginal douche once daily plus oral metronidazole 500 mg twice daily for 7 days N- Acetyl cysteine N-Acetyl cysteine the third patient group will use NAC sachets containing 200 mg as a vaginal douche only without taking metronidazole Metronidazole metronidazole the first group of patients will take oral metronidazole 500 mg twice daily for a week
- Primary Outcome Measures
Name Time Method recovery of BV one week Vaginal swabs from all patients will taken and smears will be gram stained, examined and evaluated according to Nugent scoring system afetr one week of treatment. The patient will be considered recovered if she have Nugent score of 0-3.
- Secondary Outcome Measures
Name Time Method prevention of recurrence 3 months patients who recovered after treatment will be asked for symptoms of recurrence of bacterial vaginosis and vaginal smears will be evaluated according Nugent scoring system after one month, two months and three months from the date of the end of initial treatment
Trial Locations
- Locations (1)
Minia university hospital for gynecology and obstetrics
🇪🇬Minia, Egypt