Trial record 4 of 30 for:    Open Studies | "Vaginosis, Bacterial"

Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Minia University
Sponsor:
Information provided by (Responsible Party):
Heba Ahmed Mohamed, Minia University
ClinicalTrials.gov Identifier:
NCT01841411
First received: March 15, 2013
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Bacterial Vaginosis
Drug: N-Acetyl cysteine
Drug: Metronidazole + N-Acetyl cysteine
Drug: metronidazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Studying the Role of N-Acetyl Cysteine Either Alone or in Combination With Metronidazole in Treatment of Bacterial Vaginosis

Resource links provided by NLM:


Further study details as provided by Minia University:

Primary Outcome Measures:
  • recovery of BV [ Time Frame: one week ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 90
Study Start Date: March 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Flagyl

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01841411

Contacts
Contact: Heba A Mohamed, MSc +201061398540 ham_phar@yahoo.com

Locations
Egypt
Minia university hospital for gynecology and obstetrics Recruiting
Minia, Egypt
Contact: Ahmed Re El-Adawy, Professor    +201142075858    Ahm_gyn@yahoo.com   
Sub-Investigator: Ahmed R El-Adawy, Professor         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Heba Ahmed Mohamed, principal investigator, Minia University
ClinicalTrials.gov Identifier: NCT01841411     History of Changes
Other Study ID Numbers: Microbiology2013
Study First Received: March 15, 2013
Last Updated: April 23, 2013
Health Authority: Egypt: Ministry of Higher Education

Keywords provided by Minia University:
bacterial vaginosis, recurrence, N-Acetyl cysteine

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Acetylcysteine
Metronidazole
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014