Clinical trial NCT03940612: Probiotic for Vaginal Candidiasis in Pregnant Women
Official title: Use of Probiotic for the Prevention of Re-occurrence Vaginal Candidiasis in Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Diseases
Keywords: candidiasis
probiotic
STP4
pregnant
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
Collaborators: name: SYNBIO TECH INC. Kaohsiung Taiwan
First posted: 2019-05-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo and STP4 will be administered via a parallel design
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: To evaluate STP4 in reducing frequency of vaginal candidiasis re-occurring in pregnant women
timeFrame: 8 weeks
Secondary outcomes:
measure: To assess frequency of clinical symptoms
timeFrame: 8 weeks
measure: To assess concentrations of vaginal and cervical swab, cervico vaginal lavages fluid (CVL), and fecal samples
timeFrame: 8 weeks
measure: To assess frequency in gastrointestinal symptoms
timeFrame: 8 weeks
measure: To determine health parameters of women and infants post-delivery
timeFrame: 12 months
Other outcomes:
Locations:
city: Pulau Pinang
country: Malaysia
facility: School of Industrial Technology, Universiti Sains Malaysia
state: Penang
Study officials:
affiliation: Universiti Sains Malaysia
name: Fadlina Adnan, MD
role: PRINCIPAL_INVESTIGATOR
References: