NCT03940612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 16, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

1.3 years

First QC Date

April 17, 2019

Last Update Submit

April 26, 2021

Conditions

Vaginal Diseases

Keywords

candidiasisprobioticSTP4pregnant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

STP4 (product with probiotics)

EXPERIMENTAL

Dietary Supplement: STP4

Dietary Supplement: STP4 (product with probiotics)

Placebo (product without probiotics)

EXPERIMENTAL

Dietary Supplement: Placebo

Dietary Supplement: Placebo (product without probiotics)

Interventions

STP4 (product with probiotics)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.

STP4 (product with probiotics)
Placebo (product without probiotics)DIETARY_SUPPLEMENT

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

Placebo (product without probiotics)

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSecond and third trimester pregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Industrial Technology, Universiti Sains Malaysia

Pulau Pinang, Pulau Pinang, 11800, Malaysia

Location

Related Publications (1)

  • 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.

    PMID: 38350486DERIVED

MeSH Terms

Conditions

Vaginal DiseasesCandidiasis

Interventions

Pharmaceutical PreparationsProbiotics

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesMycosesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Fadlina Adnan, MD

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Masking will be subjected to Participant, Care Provider, Investigator
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Placebo and STP4 will be administered via a parallel design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

April 17, 2019

First Posted

May 7, 2019

Study Start

June 16, 2019

Primary Completion

October 3, 2020

Study Completion

October 3, 2020

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Confidential

Locations

MY(1)