Clinical trial NCT01841411: Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis
Official title: Studying the Role of N-Acetyl Cysteine Either Alone or in Combination With Metronidazole in Treatment of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bacterial Vaginosis
Keywords: bacterial vaginosis, recurrence, N-Acetyl cysteine
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2013-04-26
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: recovery of BV
timeFrame: one week
Secondary outcomes:
measure: prevention of recurrence
timeFrame: 3 months
Other outcomes:
Locations:
city: Minia
country: Egypt
facility: Minia university hospital for gynecology and obstetrics
Study officials:
affiliation: Minia university hopital of gynecology and obstetrics
name: Ahmed R El-Adawy, Professor
role: STUDY_CHAIR
affiliation: Minia University
name: Heba A Mohamed, MSc
role: PRINCIPAL_INVESTIGATOR
References: