Probiotic for Vaginal Candidiasis in Pregnant Women

NCT ID: NCT03940612

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-16
• Study Completion Date: 2020-10-03

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.

Conditions

Vaginal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

STP4 (product with probiotics)

Dietary Supplement: STP4

Group Type: EXPERIMENTAL

STP4 (product with probiotics)

Intervention Type: DIETARY_SUPPLEMENT

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)

Dietary Supplement: Placebo

Group Type: EXPERIMENTAL

Placebo (product without probiotics)

Intervention Type: DIETARY_SUPPLEMENT

Capsules are similar to STP4 except the presence of probiotics. Administration daily for 8-weeks.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo (product without probiotics)

Capsules are similar to STP4 except the presence of probiotics. Administration daily for 8-weeks.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

SYNBIO TECH INC. Kaohsiung Taiwan

UNKNOWN

Sponsor Role: collaborator

Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Min-Tze LIONG

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fadlina Adnan, MD

Role: PRINCIPAL_INVESTIGATOR

Universiti Sains Malaysia

Locations

School of Industrial Technology, Universiti Sains Malaysia

Pulau Pinang, Pulau Pinang, Malaysia

Countries

Malaysia

References

Ang XY, Roslan NS, Ahmad N, Yusof SM, Abdullah N, Nik Ab Rahman NN, Woon JJ, Teh CS, Todorov SD, Liu G, Liong MT. Lactobacillus probiotics restore vaginal and gut microbiota of pregnant women with vaginal candidiasis. Benef Microbes. 2023 Nov 23;14(5):421-431. doi: 10.1163/18762891-20220103.

Reference Type: DERIVED

PMID: 38350486 (View on PubMed)

Other Identifiers

USM/JEPeM/18090421

Identifier Type: -

Identifier Source: org_study_id