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临床试验/NCT06474247
NCT06474247已完成2 期

Use of Postbiotic as Adjunct Treatment for Vaginal Candidiasis in Women

Min-Tze LIONG4 个研究点 分布在 2 个国家目标入组 99 人开始时间: 2024年6月2日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
99
试验地点
4
主要终点
Microbiota profiles of vaginal samples of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via next generation sequencing

研究概览

简要总结

This project aims to study the efficacy of oral administration of postbiotic at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks compared to placebo.

详细描述

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 white/yellow curd-like discharge and/or 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 81 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who are sexually active
  • Confirmed with candidiasis as confirmed via clinical observations which include creamy whitish vaginal discharge and vulva-vaginal itchiness
  • Willing to commit throughout the experiment

排除标准

  • Long term medication (6 months or more) for any illnesses
  • Menopaused
  • Uterus and/or cervix removed
  • Cervical intraepithelial neoplasia
  • Vaginal suppository treatments within 4-weeks prior to entering the study
  • Oral medication for vaginal illnesses or any vaginal therapy such as hormones and estrogen within 4-weeks prior to entering the study
  • Have used vaginal estrogen cream, ring or tablet within 4-weeks prior to entering the study
  • Have used vaginal moisturizers, lubricants or homeopathic preparations within 4-weeks prior to entering the study
  • Have used spermicide agent within 4-weeks prior to entering the study
  • Have pelvic or any gynecologic surgery 6-months prior to entering the study

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks

干预措施: Placebo (Device)

Postbiotic

Experimental

Postbiotic at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks

干预措施: Postbiotic (Device)

结局指标

主要结局

Microbiota profiles of vaginal samples of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via next generation sequencing

时间窗: 4-weeks

Differences in microbiota abundance of vaginal samples of women with vaginal candidiasis upon administration of postbiotic compared to placebo

Vulvovaginal symptoms of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via Vulvovaginal Symptoms Questionnaire (VSQ)

时间窗: 4-weeks

Differences in vulvovaginal symptoms of women with vaginal candidiasis upon administration of postbiotic compared to placebo

次要结局

  • Quality of life profiles of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via questionnaires(4-weeks)
  • Pathogenic yeasts profiles of vaginal samples of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via real time PCR(4-weeks)
  • Vaginal microbiota profiles of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via metagenomics sequencing(4-weeks)
  • Vaginal and vulvar conditions of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via the VAS-VuAS questionnaire(4-weeks)

研究者

发起方
Min-Tze LIONG
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Min-Tze LIONG

Professor

Universiti Sains Malaysia

研究点 (4)

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