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1.
Trials ; 20(1): 648, 2019 Nov 27.
Article in English | MEDLINE | ID: mdl-31775859

ABSTRACT

BACKGROUND: Bacterial vaginosis (BV) affects 30-50% of women at some time in their lives and is an embarrassing and distressing condition which can be associated with potentially serious comorbidities. Current antibiotic treatments such as metronidazole are effective but can result in side effects, and recurrence is common. This trial aims to investigate whether lactic acid gel is clinically effective and cost effective in the treatment of recurrent BV compared with metronidazole. METHODS: VITA is an open-label, multicentre, parallel group randomised controlled trial for women with a clinical diagnosis of BV and at least one previous BV episode in the past 2 years. Participants will be randomised 1:1 to intravaginal lactic acid gel 5 ml once daily for 7 days or oral metronidazole tablets 400 mg twice daily for 7 days. All participants will be followed up for 6 months to assess health status and healthcare costs. A subgroup will be interviewed to further explore adherence, tolerability and acceptability of treatment. The estimated sample size is 1900 participants to detect a 6% absolute increase in response rate to 86% in those receiving lactic acid gel. The primary outcome is participant-reported resolution of BV at Week 2. DISCUSSION: Results from this trial will help inform UK treatment guidelines for BV and may provide an alternative effective treatment for recurrent episodes of this condition which avoids repeated exposure to antibiotics. TRIAL REGISTRATION: ISRCTN, ISRCTN14161293. Registered on 8 September 2017.


Subject(s)
Anti-Bacterial Agents/administration & dosage , Drug Costs , Lactic Acid/administration & dosage , Lactic Acid/economics , Metronidazole/administration & dosage , Metronidazole/economics , Vaginosis, Bacterial/drug therapy , Vaginosis, Bacterial/economics , Administration, Intravaginal , Anti-Bacterial Agents/adverse effects , Anti-Bacterial Agents/economics , Comparative Effectiveness Research , Cost-Benefit Analysis , Female , Gels , Humans , Lactic Acid/adverse effects , Metronidazole/adverse effects , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Recurrence , Retreatment/economics , Time Factors , Treatment Outcome , United Kingdom , Vaginosis, Bacterial/diagnosis , Vaginosis, Bacterial/microbiology
2.
J Am Acad Dermatol ; 73(6): 1040-54.e14, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26481056

ABSTRACT

HIV facial lipoatrophy (FLA) is characterized by facial volume loss. HIV FLA affects the facial contours of the cheeks, temples, and orbits, and is associated with social stigma. Although new highly active antiretroviral therapy medications are associated with less severe FLA, the prevalence of HIV FLA among treated individuals exceeds 50%. The goal of our systematic review is to examine published clinical studies involving the use of filler agents for aesthetic treatment of HIV FLA and to provide evidence-based recommendations based on published efficacy and safety data. A systematic review of the published literature was performed on July 1, 2015, on filler agents for aesthetic treatment of HIV FLA. Based on published studies, poly-L-lactic acid is the only filler agent with grade of recommendation: B. Other reviewed filler agents received grade of recommendation: C or D. Poly-L-lactic acid may be best for treatment over temples and cheeks, whereas calcium hydroxylapatite, with a Food and Drug Administration indication of subdermal implantation, may be best used deeply over bone for focal enhancement. Additional long-term randomized controlled trials are necessary to elucidate the advantages and disadvantages of fillers that have different biophysical properties, in conjunction with cost-effectiveness analysis, for treatment of HIV FLA.


Subject(s)
Dermal Fillers/administration & dosage , Face , HIV-Associated Lipodystrophy Syndrome/therapy , Lactic Acid/administration & dosage , Polymers/administration & dosage , Cosmetic Techniques , Cost-Benefit Analysis , Dermal Fillers/economics , Esthetics , Female , HIV-Associated Lipodystrophy Syndrome/diagnosis , Humans , Lactic Acid/economics , Male , Polyesters , Polymers/economics , Risk Assessment , Severity of Illness Index , Treatment Outcome
3.
Microb Biotechnol ; 8(2): 221-9, 2015 Mar.
Article in English | MEDLINE | ID: mdl-24894833

ABSTRACT

Lactic acid is an intermediate-volume specialty chemical for a wide range of food and industrial applications such as pharmaceuticals, cosmetics and chemical syntheses. Although lactic acid production has been well documented, improved production parameters that lead to reduced production costs are always of interest in industrial developments. In this study, we describe the production of lactic acid at high concentration, yield and volumetric productivity utilizing a novel homofermentative, facultative anaerobe Enterococcus faecalis CBRD01. The highest concentration of 182 g lactic acid l(-1) was achieved after 38 h of fed-batch fermentation on glucose. The bacterial isolate utilized only 2-13% of carbon for its growth and energy metabolism, while 87-98% of carbon was converted to lactic acid at an overall volumetric productivity of 5 g l(-1) h(-1). At 13 h of fermentation, the volumetric productivity of lactate production reached 10.3 g l(-1) h(-1), which is the highest ever reported for microbial production of lactic acid. The lactic acid produced was of high purity as formation of other metabolites was less than 0.1%. The present investigation demonstrates a new opportunity for enhanced production of lactic acid with potential for reduced purification costs.


Subject(s)
Enterococcus faecalis/metabolism , Lactic Acid/metabolism , Biotechnology/economics , Biotechnology/methods , Carbon/metabolism , Energy Metabolism , Enterococcus faecalis/growth & development , Fermentation , Lactic Acid/economics , Time Factors
4.
Bioresour Technol ; 135: 475-80, 2013 May.
Article in English | MEDLINE | ID: mdl-23127843

ABSTRACT

Highly efficient L-lactate production by a thermophilic strain Bacillus sp. NL01 was demonstrated in this study. Lignocellulosic hydrolyzates containing a high content of glucose, which was prepared from corn stover, was used as substrate for L-lactic acid production. The fermentation was carried out under open condition without sterilization and used NaOH as alkaline neutralizing reagent. In batch fermentation, 56.37 g l(-1) L-lactic acid was obtained from lignocellulosic hydrolyzates which contained the solid residues produced in enzymatic saccharification. In fed-batch fermentation, 75.03 g l(-1) L-lactic acid was obtained from lignocellulosic hydrolyzates supernatant. The yield was 74.5% and the average productivity was 1.04 g l(-1) h(-1).


Subject(s)
Bacillus/metabolism , Fermentation , Lactic Acid/biosynthesis , Lactic Acid/economics , Lignin/metabolism , Bacillus/drug effects , Batch Cell Culture Techniques , Costs and Cost Analysis , Glucose/pharmacology , Hydrogen-Ion Concentration/drug effects , Hydrolysis/drug effects , Steam , Temperature , Time Factors , Zea mays/drug effects
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