Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis

NCT01841411 | Unknown Phase 4 DMC

• 1 other identifier: Microbiology2013
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginosis

Keywords

bacterial vaginosis, recurrence, N-Acetyl cysteine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• prevention of recurrence

  3 months

Study Arms (3)

Metronidazole + N-Acetyl cysteine

EXPERIMENTAL

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

N- Acetyl cysteine

EXPERIMENTAL

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

Drug: N-Acetyl cysteine

Metronidazole

ACTIVE COMPARATOR

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

Drug: metronidazole

Interventions

N-Acetyl cysteine 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.

Also known as: Acetyl cistein

N- Acetyl cysteine

Metronidazole + N-Acetyl cysteine 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

Also known as: Flagyl, Acetyl cistein

Metronidazole + N-Acetyl cysteine

metronidazole 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

Also known as: Flagyl

Metronidazole

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients complaining bacterial vaginosis and proved to have BV using standard diagnostic methods for BV
• patients with age between 20-50

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia university hospital for gynecology and obstetrics

Minya, Egypt

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial; Recurrence

Interventions

Acetylcysteine; Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ahmed R El-Adawy, Professor

  Minia university hopital of gynecology and obstetrics

  STUDY CHAIR

• Heba A Mohamed, MSc

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heba A Mohamed, MSc

CONTACT

+201061398540; ham_phar@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: April 26, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 26, 2013

Record last verified: 2013-04

Locations

EG (1)