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临床试验/NCT03940612
NCT03940612已完成不适用

Use of Probiotic for the Prevention of Re-occurrence Vaginal Candidiasis in Pregnant Women

Universiti Sains Malaysia2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
To evaluate STP4 in reducing frequency of vaginal candidiasis re-occurring in pregnant women

研究概览

简要总结

This project aims to study the benefits of a probiotic product, STP4 for vaginal health properties, primarily prevention of vaginal candidiasis, among pregnant women in second and third trimester pregnancy.

详细描述

Probiotic 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.

Vaginal candidiasis can occur randomly in pregnant women. Vaginitis has been considered as one of the most common gynaecological condition affecting women worldwide. 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, pruritus, dyspareunia, dysuria, irritation, soreness of the vulva and other discomforting symptoms that will ensure frequent hospital visits.

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. Moreover, the majority of women who have vaginal yeast also carry the organism in the gut. The typical rate of yeast carriage varies among populations and increases both after puberty and during pregnancy, which suggests an important role for pregnancy in cases of vaginal candidiasis. Probiotics are preferred compared to antibacterial drugs, such as clindamycin and metronidazole used for bacterial vaginosis treatment 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. Therefore, it is vital to find other alternatives to treat vaginal infections.

STP4 is manufactured under a HACCP and ISO 22000 certified manufacturing plant. The HACCP Codex Alimentarius is applied for the production of powdered Probiotics and Lactic Acid Bacteria used as food ingredients and the production of probiotics fermented solution used as food ingredients. The manufacturing plant also has been certified by Taiwan Quality Food (TQF) Scheme which they have met the requirement by Food Industry Research and Development Institute with the scope of processing of Ambient stable products. STP4 does not contain any porcine or bovine ingredients and has obtained the HALAL certification from Taiwan Halal Integrity Development Association (THIDA), Taiwan, which is recognized by JAKIM, Malaysia. STP4 capsules several strains of lactobacilli. The strains are Lactobacillus plantarum LP115, Lactobacillus helveticus LA25, Lactobacillus rhamnosus LRH10, Lactobacillus paracasei LPC12, Lactobacillus fermentum LF26, and Lactobacillus delbrueckii subsp. lactis LDL114. One capsule contains not less than 9.5 CFU of lactobacilli. The other ingredients are maltodextrin added with the ingredients and capsule shell made of hydroxypropyl methylcellulose.

A total number of 80 pregnant women (second and third trimester pregnancy) will be recruited for this study.

研究设计

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

盲法说明

Masking will be subjected to Participant, Care Provider, Investigator

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women
  • 14-32 weeks pregnancy
  • Confirmed vaginal candidiasis
  • Positive vaginal yeast culture
  • Willing to commit throughout the experiment

排除标准

  • Self-declared illness that may have a potential to establish "leaky gut"
  • Type-1 diabetes
  • Long term medication (6 months or more) due to certain severe illness
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency

结局指标

主要结局

To evaluate STP4 in reducing frequency of vaginal candidiasis re-occurring in pregnant women

时间窗: 8 weeks

To determine if oral administration of STP4 at 10 log CFU/day could reduce frequency (number and duration of times), of reoccurrence of vaginal candidiasis in pregnant women for 8-weeks compared to placebo

次要结局

  • To assess frequency of clinical symptoms(8 weeks)
  • To assess concentrations of vaginal and cervical swab, cervico vaginal lavages fluid (CVL), and fecal samples(8 weeks)
  • To assess frequency in gastrointestinal symptoms(8 weeks)
  • To determine health parameters of women and infants post-delivery(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Min-Tze LIONG

Prof. Dr.

Universiti Sains Malaysia

研究点 (2)

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