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Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis

Primary Purpose

Bacterial Vaginosis

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
N-Acetyl cysteine
Metronidazole + N-Acetyl cysteine
metronidazole
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginosis focused on measuring bacterial vaginosis, recurrence, N-Acetyl cysteine

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Minia university hospital for gynecology and obstetricsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Metronidazole + N-Acetyl cysteine

N- Acetyl cysteine

Metronidazole

Arm 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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 15, 2013
Last Updated
April 23, 2013
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT01841411
Brief Title
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

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
Keywords
bacterial vaginosis, recurrence, N-Acetyl cysteine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metronidazole + N-Acetyl cysteine
Arm Type
Experimental
Arm 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
Arm Title
N- Acetyl cysteine
Arm Type
Experimental
Arm Description
the third patient group will use NAC sachets containing 200 mg as a vaginal douche only without taking metronidazole
Arm Title
Metronidazole
Arm Type
Active Comparator
Arm Description
the first group of patients will take oral metronidazole 500 mg twice daily for a week
Intervention Type
Drug
Intervention Name(s)
N-Acetyl cysteine
Other Intervention Name(s)
Acetyl cistein
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Metronidazole + N-Acetyl cysteine
Other Intervention Name(s)
Flagyl, Acetyl cistein
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
metronidazole
Other Intervention Name(s)
Flagyl
Intervention Description
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
Primary Outcome Measure Information:
Title
recovery of BV
Description
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.
Time Frame
one week
Secondary Outcome Measure Information:
Title
prevention of recurrence
Description
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
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heba A Mohamed, MSc
Phone
+201061398540
Email
ham_phar@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed R El-Adawy, Professor
Organizational Affiliation
Minia university hopital of gynecology and obstetrics
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Heba A Mohamed, MSc
Organizational Affiliation
Minia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minia university hospital for gynecology and obstetrics
City
Minia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Re El-Adawy, Professor
Phone
+201142075858
Email
Ahm_gyn@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ahmed R El-Adawy, Professor

12. IPD Sharing Statement

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Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis

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