Probiotic for Vaginal Candidiasis in Pregnant Women
Condition: Vaginal Diseases
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Vaginal Diseases
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): STP4 (product with probiotics); Placebo (product without probiotics)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): STP4 contains Lactobacillus plantarum LP115, Lactobacillus helveticus LA25, Lactobacillus rhamnosus LRH10, Lactobacillus paracasei LPC12, Lactobacillus fermentum LF26, Lactobacillus delbrueckii subsp. lactis, LDL114. Administration at 10 log CFU/day for 8-weeks.; Capsules are similar to STP4 except the presence of probiotics. Administration daily for 8-weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo and STP4 will be administered via a parallel design
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: candidiasis; probiotic; STP4; pregnant