- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01841411
Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis
Studying the Role of N-Acetyl Cysteine Either Alone or in Combination With Metronidazole in Treatment of Bacterial Vaginosis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Heba A Mohamed, MSc
- Phone Number: +201061398540
- Email: ham_phar@yahoo.com
Study Locations
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Minia, Egypt
- Recruiting
- Minia university hospital for gynecology and obstetrics
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Contact:
- Ahmed Re El-Adawy, Professor
- Phone Number: +201142075858
- Email: Ahm_gyn@yahoo.com
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Sub-Investigator:
- Ahmed R El-Adawy, Professor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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 Names:
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Experimental: N- Acetyl cysteine
the third patient group will use NAC sachets containing 200 mg as a vaginal douche only without taking metronidazole
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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 Names:
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Active Comparator: Metronidazole
the first group of patients will take oral metronidazole 500 mg twice daily for a week
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recovery of BV
Time Frame: one week
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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.
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one week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevention of recurrence
Time Frame: 3 months
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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
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ahmed R El-Adawy, Professor, Minia university hopital of gynecology and obstetrics
- Principal Investigator: Heba A Mohamed, MSc, Minia University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Vaginitis
- Vaginal Diseases
- Vaginosis, Bacterial
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Anti-Bacterial Agents
- Respiratory System Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Metronidazole
- Acetylcysteine
- N-monoacetylcystine
Other Study ID Numbers
- Microbiology2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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