Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis

NCT ID: NCT01841411

Last Updated: 2013-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-06-30

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.

Conditions

Bacterial Vaginosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Metronidazole + N-Acetyl cysteine

Intervention Type: DRUG

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

N- Acetyl cysteine

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

Group Type: EXPERIMENTAL

N-Acetyl cysteine

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

metronidazole

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Acetyl cistein; Flagyl, Acetyl cistein; Flagyl

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Heba Ahmed Mohamed

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed R El-Adawy, Professor

Role: STUDY_CHAIR

Minia university hopital of gynecology and obstetrics

Heba A Mohamed, MSc

Role: PRINCIPAL_INVESTIGATOR

Minia University

Locations

Minia university hospital for gynecology and obstetrics

Minya, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Heba A Mohamed, MSc

Role: CONTACT

ham_phar@yahoo.com

+201061398540

Facility Contacts

Ahmed Re El-Adawy, Professor

Role: primary

Ahm_gyn@yahoo.com

+201142075858

Other Identifiers

Microbiology2013

Identifier Type: -

Identifier Source: org_study_id