Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis

Bacterial Vaginosis Clinical Trial

Official title:

Studying the Role of N-Acetyl Cysteine Either Alone or in Combination With Metronidazole in Treatment of Bacterial Vaginosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01841411
• Other study ID #: Microbiology2013
• Status: Recruiting
• Phase: Phase 4
• First received: March 15, 2013
• Last updated: April 23, 2013
• Start date: March 2013
• Est. completion date: June 2013

Study information

• Verified date: April 2013
• Source: Minia University
• Contact: Heba A Mohamed, MSc
• Phone: +201061398540
• Email: ham_phar[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• N-Acetyl cysteine
N-Acetyl cysteine is a pharmaceutical drug and nutritional supplement,it is a derivative of the natural amino acid cysteine, from which it differs by virtue of the introduction of an acetyl group on the nitrogen atom of the amino terminal.It is used mainly as a mucolytic and in management of paracetamol overdose. It has been observed that N-acetyl cysteine has shown good properties in terms of combating bacterial infections. In particular, it has been observed that NAC presents good activity in terms of inhibiting bacterial adhesion and in dissolving the biofilm matrix.
• Metronidazole + N-Acetyl cysteine
Metronidazole is an antibiotic effective against anaerobic bacteria and certain parasites.It can be used in treatment of vaginal infections such as trichomoniasis and bacterial vaginosis N-Acetyl cysteine is a pharmaceutical drug and nutritional supplement, It is used mainly as a mucolytic and in management of paracetamol overdose. It has been observed that N-acetyl cysteine has antibacterial and antibiofilm activities
• metronidazole
Metronidazole is an antibiotic effective against anaerobic bacteria and certain parasites.It can be used in treatment of vaginal infections such as trichomoniasis and bacterial vaginosis in treatment of bacterial vaginosis, it can be used in treatment of bacterial vaginosis either in a dose of 500 mg twice daily or 250 mg three times daily for seven days

Locations

Country	Name	City	State
Egypt	Minia university hospital for gynecology and obstetrics	Minia

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recovery of BV	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.	one week	No
Secondary	prevention of recurrence	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	3 months	No