Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis

Minia University

Status and phase: Unknown; Phase 4

Conditions: Bacterial Vaginosis

Treatments: Drug: metronidazole; Drug: N-Acetyl cysteine; Drug: Metronidazole + N-Acetyl cysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT01841411

Microbiology2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients complaining bacterial vaginosis and proved to have BV using standard diagnostic methods for BV
• patients with age between 20-50

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

Metronidazole + N-Acetyl cysteine

Experimental group

Description:

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

Treatment:

Drug: Metronidazole + N-Acetyl cysteine

N- Acetyl cysteine

Experimental group

Description:

the third patient group will use NAC sachets containing 200 mg as a vaginal douche only without taking metronidazole

Treatment:

Drug: N-Acetyl cysteine

Metronidazole

Active Comparator group

Description:

the first group of patients will take oral metronidazole 500 mg twice daily for a week

Treatment:

Drug: metronidazole