Probiotic for Vaginal Candidiasis in Pregnant Women

Vaginal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940612
• Other study ID #: USM/JEPeM/18090421
• Status: Completed
• Phase: N/A
• Start date: June 16, 2019
• Est. completion date: October 3, 2020

Study information

• Verified date: April 2021
• Source: Universiti Sains Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 3, 2020
• Est. primary completion date: October 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vaginal Diseases

Intervention

Dietary Supplement:
• STP4 (product with probiotics)
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.
• Placebo (product without probiotics)
Capsules are similar to STP4 except the presence of probiotics. Administration daily for 8-weeks.

Locations

Country	Name	City	State
Malaysia	School of Industrial Technology, Universiti Sains Malaysia	Pulau Pinang	Penang

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Sains Malaysia	SYNBIO TECH INC. Kaohsiung Taiwan

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate STP4 in reducing frequency of vaginal candidiasis re-occurring in pregnant women	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	8 weeks
Secondary	To assess frequency of clinical symptoms	To determine if oral administration of STP4 at 10 log CFU/day could reduce frequency (number and duration of times) of clinical symptoms as assessed via questionnaire on vaginal candidiasis in pregnant women for 8-weeks compared to placebo. Questionnaire used is the Vulvovaginal Symptom Questionnaire (VSQ). Each of the 21 questions is answered as yes or no. Each yes carries 1 mark. A higher total score represents increase vulvovaginal symptom bother.	8 weeks
Secondary	To assess concentrations of vaginal and cervical swab, cervico vaginal lavages fluid (CVL), and fecal samples	Concentrations include microbiota compositions, concentrations of cytokines and gene expressions of vaginal and cervical swab, cervico vaginal lavages fluid (CVL), and fecal samples of pregnant women on STP4 and placebo	8 weeks
Secondary	To assess frequency in gastrointestinal symptoms	To determine if oral administration of STP4 at 10 log CFU/day could reduce frequency (number and duration of times), of gastrointestinal symptoms as assessed via questionnaire in pregnant women with candidiasis for 8-weeks compared to placebo	8 weeks
Secondary	To determine health parameters of women and infants post-delivery	Parameters include health profiles of women and infants post-delivery as assessed via standard hospital medical records, from pregnant women on STP4 and placebo	12 months