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Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis

Information source: Minia University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Vaginosis

Intervention: N-Acetyl cysteine (Drug); Metronidazole + N-Acetyl cysteine (Drug); metronidazole (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Minia University

Official(s) and/or principal investigator(s):
Ahmed R El-Adawy, Professor, Study Chair, Affiliation: Minia university hopital of gynecology and obstetrics
Heba A Mohamed, MSc, Principal Investigator, Affiliation: Minia University

Overall contact:
Heba A Mohamed, MSc, Phone: +201061398540, Email: ham_phar@yahoo.com

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.

Clinical Details

Official title: Studying the Role of N-Acetyl Cysteine Either Alone or in Combination With Metronidazole in Treatment of Bacterial Vaginosis

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: recovery of BV

Secondary outcome: 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.

Eligibility

Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Female.

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

Locations and Contacts

Heba A Mohamed, MSc, Phone: +201061398540, Email: ham_phar@yahoo.com

Minia university hospital for gynecology and obstetrics, Minia, Egypt; Recruiting
Ahmed Re El-Adawy, Professor, Phone: +201142075858, Email: Ahm_gyn@yahoo.com
Ahmed R El-Adawy, Professor, Sub-Investigator
Additional Information

Starting date: March 2013
Last updated: April 23, 2013

Page last updated: August 23, 2015

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