Ignite Creation Date:
2024-07-17 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474247
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-19
Brief Title:
Postbiotic as Adjunct Treatment for Vaginal Candidiasis
Sponsor:
Min-Tze LIONG
Organization:
Universiti Sains Malaysia
Study Overview
Official Title:
Use of Postbiotic as Adjunct Treatment for Vaginal Candidiasis in Women
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project aims to study the efficacy of intravaginal administration of postbiotic at 1gday as an adjunct treatment against vaginal candidiasis in women for 4-weeks compared to placebo
Detailed Description:
Probiotics are live microorganisms that grant health effects to the host if consumed in sufficient amounts Probiotic bacteria which beneficially affect the host by improving the intestinal microbial balance may affect the immune response thus boosting the body system to combat against diseases Meanwhile postbiotic is an inactivated probiotic probiotic-produced metabolites or their combination which is capable of conferring beneficial effects to the host Postbiotic has added advantages as compared to probiotic where inactivated cellular components remain potent though excluding any allergic factors while the beneficial metabolites are applied directly to host upon administration and useful for applications such as skin topical use and intravaginal routes
Vaginitis has been considered as one of the most common gynaecological conditions affecting women worldwide Bacterial vaginosis and yeast vaginitis are two of three urogenital infections that affect as estimated one billion women in the world annually The prevalence of vaginitis was reported to be varied from 5 to 50 among different study populations across major continents such as the United States of America Europe and South Asia
Vaginal candidiasis is one of the most common gynecological problems seen in primary care with Candida albicans account for 90 of the infection The over-growth of this fungus in the vagina leads to a burning sensation in the vagina vulva the production of heavy whiteyellow curd-like discharge andor an itchy vulva puritus dyspareunia dysuria irritation soreness of the vulva and other discomforting symptoms that will ensure frequent hospital visits The symptoms of vaginal candidiasis include vaginal itching or soreness pain during sexual intercourse pain or discomfort when urinating and abnormal vaginal discharge Although most vaginal candidiasis is mild some women can develop severe infections involving redness swelling and cracks in the wall of the vagina It is also a most common form of fungal infection in pregnant mothers which may cause systemic infections in neonate particularly with low birth weight and prematurity after delivery
Probiotics are preferred compared to antibacterial and antifungal drugs due to infection recurrence and drug resistance It is a main concern that overuse of antibiotics could result in the development of antibiotic-resistant bacteria and fungus Therefore it is vital to find other alternatives to treat vaginal infections
The maintenance of healthy vaginal microbiota is important for optimal vaginal microenvironment Jang and team reported that intravaginal administration of probiotic mixture increased the regulation of vaginal IL-10 and Foxp3 As this may be due to the probiotic regulatory effects on immune responses in the vagina A clinical study from Norway and Sweden found that the treatment with antibiotics or anti-fungal medication in combination with probiotics provided long-term cure against recurrence of vaginal candidiasis as compared to the control
During the past several decades the many published surveys of vaginal flora specimens obtained from asymptomatic women have clearly shown that C albicans may be present without the typical symptoms of yeast vaginitis In a study by Glover and Larsen the results of successive cultures of vaginal flora specimens indicated that Candida species may be present in stable association with the genital epithelium Moreover the majority of women who have vaginal yeast also carry the organism in the gut
In women vaginal candidiasis has been related to emotional stress and suppression of immune system which step up the risk of Candida species overgrowth and become pathogenic In addition another study involving 512 women with candidiasiss reported a substantial negative impact on quality of life with 42 feeling out of control of their lives and 60 feeling out of control of their bodies Forty-one percent indicated a severe impact on their sexual lives Meanwhile 30 of women with recurrent episodes of candidiasis have reported considerable morbidity and suffering The summary scores of the SF-36 in topic of subjective health status and health-related quality of life among women with Recurrent Vulvovaginal Candidosis RVVC in Europe and the USA also suggested that mental health was strongly affected by RVVC
Current reports primarily emphasize on clinical effects of probiotics against candidiasis in women with only few reports specifically on efficacy against recurrences Very recent data are beginning to report on microbiota profiles of vaginal and feces of women with candidiasis albeit rare There have been no reports on these aspects from postbiotics Information on proteins concentration gene expression of vaginal microenvironment as affected by postbiotics against candidiasis are thus crucial Thus it is hoped that via this research new scientific data is generated for future knowledge on these aspects for use of postbiotics as an adjunct treatment against VC and RVVC
Vaginitis has been considered as one of the most common gynaecological conditions affecting women worldwide Bacterial vaginosis and yeast vaginitis are two of three urogenital infections that affect as estimated one billion women in the world annually The prevalence of vaginitis was reported to be varied from 5 to 50 among different study populations across major continents such as the United States of America Europe and South Asia
Vaginal candidiasis is one of the most common gynecological problems seen in primary care with Candida albicans account for 90 of the infection The over-growth of this fungus in the vagina leads to a burning sensation in the vagina vulva the production of heavy whiteyellow curd-like discharge andor an itchy vulva puritus dyspareunia dysuria irritation soreness of the vulva and other discomforting symptoms that will ensure frequent hospital visits The symptoms of vaginal candidiasis include vaginal itching or soreness pain during sexual intercourse pain or discomfort when urinating and abnormal vaginal discharge Although most vaginal candidiasis is mild some women can develop severe infections involving redness swelling and cracks in the wall of the vagina It is also a most common form of fungal infection in pregnant mothers which may cause systemic infections in neonate particularly with low birth weight and prematurity after delivery
Probiotics are preferred compared to antibacterial and antifungal drugs due to infection recurrence and drug resistance It is a main concern that overuse of antibiotics could result in the development of antibiotic-resistant bacteria and fungus Therefore it is vital to find other alternatives to treat vaginal infections
The maintenance of healthy vaginal microbiota is important for optimal vaginal microenvironment Jang and team reported that intravaginal administration of probiotic mixture increased the regulation of vaginal IL-10 and Foxp3 As this may be due to the probiotic regulatory effects on immune responses in the vagina A clinical study from Norway and Sweden found that the treatment with antibiotics or anti-fungal medication in combination with probiotics provided long-term cure against recurrence of vaginal candidiasis as compared to the control
During the past several decades the many published surveys of vaginal flora specimens obtained from asymptomatic women have clearly shown that C albicans may be present without the typical symptoms of yeast vaginitis In a study by Glover and Larsen the results of successive cultures of vaginal flora specimens indicated that Candida species may be present in stable association with the genital epithelium Moreover the majority of women who have vaginal yeast also carry the organism in the gut
In women vaginal candidiasis has been related to emotional stress and suppression of immune system which step up the risk of Candida species overgrowth and become pathogenic In addition another study involving 512 women with candidiasiss reported a substantial negative impact on quality of life with 42 feeling out of control of their lives and 60 feeling out of control of their bodies Forty-one percent indicated a severe impact on their sexual lives Meanwhile 30 of women with recurrent episodes of candidiasis have reported considerable morbidity and suffering The summary scores of the SF-36 in topic of subjective health status and health-related quality of life among women with Recurrent Vulvovaginal Candidosis RVVC in Europe and the USA also suggested that mental health was strongly affected by RVVC
Current reports primarily emphasize on clinical effects of probiotics against candidiasis in women with only few reports specifically on efficacy against recurrences Very recent data are beginning to report on microbiota profiles of vaginal and feces of women with candidiasis albeit rare There have been no reports on these aspects from postbiotics Information on proteins concentration gene expression of vaginal microenvironment as affected by postbiotics against candidiasis are thus crucial Thus it is hoped that via this research new scientific data is generated for future knowledge on these aspects for use of postbiotics as an adjunct treatment against VC and RVVC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None