Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis
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|ClinicalTrials.gov Identifier: NCT01841411|
Recruitment Status : Unknown
Verified April 2013 by Heba Ahmed Mohamed, Minia University.
Recruitment status was: Recruiting
First Posted : April 26, 2013
Last Update Posted : April 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Vaginosis||Drug: N-Acetyl cysteine Drug: Metronidazole + N-Acetyl cysteine Drug: metronidazole||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Studying the Role of N-Acetyl Cysteine Either Alone or in Combination With Metronidazole in Treatment of Bacterial Vaginosis|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||June 2013|
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
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
- recovery of BV [ Time Frame: one week ]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.
- prevention of recurrence [ Time Frame: 3 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841411
|Contact: Heba A Mohamed, MScfirstname.lastname@example.org|
|Minia university hospital for gynecology and obstetrics||Recruiting|
|Contact: Ahmed Re El-Adawy, Professor +201142075858 Ahm_gyn@yahoo.com|
|Sub-Investigator: Ahmed R El-Adawy, Professor|
|Study Chair:||Ahmed R El-Adawy, Professor||Minia university hopital of gynecology and obstetrics|
|Principal Investigator:||Heba A Mohamed, MSc||Minia University|