Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis

April 23, 2013 updated by: Heba Ahmed Mohamed, Minia University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Minia, Egypt
        • Recruiting
        • Minia university hospital for gynecology and obstetrics
        • Contact:
        • Sub-Investigator:
          • Ahmed R El-Adawy, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: 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
Other Names:
  • Flagyl, Acetyl cistein
Experimental: N- Acetyl cysteine
the third patient group will use NAC sachets containing 200 mg as a vaginal douche only without taking metronidazole
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.
Other Names:
  • Acetyl cistein
Active Comparator: Metronidazole
the first group of patients will take oral metronidazole 500 mg twice daily for a week
Drug: 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
Other Names:
  • Flagyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recovery of BV
Time Frame: 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.
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevention of recurrence
Time Frame: 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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Study Chair: Ahmed R El-Adawy, Professor, Minia university hopital of gynecology and obstetrics
  • Principal Investigator: Heba A Mohamed, MSc, Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

March 15, 2013

First Submitted That Met QC Criteria

April 23, 2013

First Posted (Estimate)

April 26, 2013

Study Record Updates

Last Update Posted (Estimate)

April 26, 2013

Last Update Submitted That Met QC Criteria

April 23, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Microbiology2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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