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Bacterial Vaginosis | Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis

Bacterial Vaginosis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Bacterial Vaginosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:N-Acetyl cysteineN-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.

Drug:Metronidazole + N-Acetyl cysteineMetronidazole 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

Drug:metronidazoleMetronidazole 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Metronidazole + N-Acetyl cysteinethe 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

N- Acetyl cysteinethe third patient group will use NAC sachets containing 200 mg as a vaginal douche only without taking metronidazole

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

Study Status

Unknown status

Start Date: March 2013

Completed Date: June 2013

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: recovery of BV

Secondary Outcome: prevention of recurrence

Study sponsors, principal investigator, and references

Principal Investigator: Ahmed R El-Adawy, Professor

Lead Sponsor: Minia University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01841411

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