Vaginal DiseasesNCT03940612
Probiotic for Vaginal Candidiasis in Pregnant Women
A study testing STP4 (product with probiotics) in people with Vaginal Diseases, run by Universiti Sains Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Diseases
- What is being tested?
- STP4 (product with probiotics)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteMalaysia
- Study dates
- 16 Jun 2019to 3 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women
- 14-32 weeks pregnancy
- Confirmed vaginal candidiasis
- Positive vaginal yeast culture
- Willing to commit throughout the experiment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
School of Industrial Technology, Universiti Sains Malaysia
Pulau Pinang, Pulau Pinang, 11800
About this study
Official title: Use of Probiotic for the Prevention of Re-occurrence Vaginal Candidiasis in Pregnant Women
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.
Read the 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
- Being tested
- STP4 (product with probiotics), Placebo (product without probiotics)
- Keywords
- candidiasis, probiotic, STP4, pregnant
- Medical subject headings
- Vaginal Diseases, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Placebo (product without probiotics)Dietary supplement
Capsules are similar to STP4 except the presence of probiotics. Administration daily for 8-weeks.
| Study group | Role | What they receive |
|---|---|---|
| STP4 (product with probiotics) | Experimental | Dietary Supplement: STP4 Receives: Dietary Supplement: STP4 (product with probiotics) |
| Placebo (product without probiotics) | Experimental | Dietary Supplement: Placebo Receives: Dietary Supplement: Placebo (product without probiotics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (4)
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.
Measured: 8 weeks
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
Measured: 8 weeks
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
Measured: 8 weeks
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start16 Jun 2019
- Primary completion3 Oct 2020
- Study completion3 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo and STP4 will be administered via a parallel design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- SYNBIO TECH INC. Kaohsiung Taiwan
- Responsible party
- Principal investigator, Min-Tze LIONG, Universiti Sains Malaysia
- Investigators
- Fadlina Adnan, MD, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940612
- Sponsor's protocol ID
- USM/JEPeM/18090421
- Status last verified
- Apr 2021
- First submitted
- 17 Apr 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential
Publications
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.
PubMed 38350486
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Probiotic for the Prevention of Re-occurrence Vaginal Candidiasis in Pregnant Women
- ClinicalTrials.gov ID
- NCT03940612
- Acronym / sponsor ID
- USM/JEPeM/18090421
- Conditions
- Vaginal Diseases
- Keywords
- candidiasis, probiotic, STP4, pregnant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- SYNBIO TECH INC. Kaohsiung Taiwan
- Study start
- 16 Jun 2019 (actual)
- Primary completion
- 3 Oct 2020 (actual)
- Study completion
- 3 Oct 2020 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Placebo and STP4 will be administered via a parallel design
| Arm | Type | Receives |
|---|---|---|
| STP4 (product with probiotics) | Experimental | Dietary Supplement: STP4 (product with probiotics)Dietary Supplement: STP4 |
| Placebo (product without probiotics) | Experimental | Dietary Supplement: Placebo (product without probiotics)Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women
- 14-32 weeks pregnancy
- Confirmed vaginal candidiasis
- Positive vaginal yeast culture
- Willing to commit throughout the experiment
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | STP4 (product with probiotics) |
| Placebo (product without probiotics)Capsules are similar to STP4 except the presence of probiotics. Administration daily for 8-weeks. | Dietary supplement | Placebo (product without probiotics) |
Primary outcome
To evaluate STP4 in reducing frequency of vaginal candidiasis re-occurring in pregnant women
Time frame: 8 weeks
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
4 secondary outcomes
To assess frequency of clinical symptoms
Time frame: 8 weeks
To assess concentrations of vaginal and cervical swab, cervico vaginal lavages fluid (CVL), and fecal samples
Time frame: 8 weeks
To assess frequency in gastrointestinal symptoms
Time frame: 8 weeks
To determine health parameters of women and infants post-delivery
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 38350486Ang 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.
- Individual participant dataSharing planned: No. Confidential
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fadlina Adnan, MD principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STP4 (product with probiotics) in people with Vaginal Diseases, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate STP4 in reducing frequency of vaginal candidiasis re-occurring in pregnant women (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03940612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.