Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000204549
Ethics application status
Approved
Date submitted
30/01/2024
Date registered
1/03/2024
Date last updated
1/03/2024
Date data sharing statement initially provided
1/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Oral safety and efficacy of eucalypt sap resin in the management of recurrent vulvovaginal candidiasis
Scientific title
Pilot oral safety and efficacy of eucalypt sap resin for the management of recurrent vulvovaginal candidiasis (RVVC) and associated gastrointestinal symptoms: A comparative, 2-arm, double-blinded randomised study
Secondary ID [1] 311432 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
recurrent vulvovaginal candidiasis 332719 0
Condition category
Condition code
Alternative and Complementary Medicine 329434 329434 0 0
Herbal remedies
Infection 329435 329435 0 0
Other infectious diseases
Renal and Urogenital 329607 329607 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be directed to take one capsule orally per day in the morning, with food for 24 weeks.
Arm A capsules - contain 700 mg of powdered Eucalypt sap resin
Compliance will be monitored by return capsule count
A subset of women in each group (maximum n=12) will be offered vaginal microbiome testing. This is exploratory testing and will be offered at the researchers discretion.

Intervention code [1] 327876 0
Prevention
Intervention code [2] 328087 0
Treatment: Drugs
Comparator / control treatment
Participants will be directed to take one capsule orally per day in the morning, with food for 24 weeks.
Arm B capsules - contain 700 mg of powdered Corymbia sap resin
Compliance will be monitored by return capsule count
A subset of women in each group (maximum n=12) will be offered vaginal microbiome testing. This is exploratory testing and will be offered at the researchers discretion.
Control group
Active

Outcomes
Primary outcome [1] 337256 0
Safety
Timepoint [1] 337256 0
baseline, 12 weeks and 24 weeks post-treatment commencement
Secondary outcome [1] 431216 0
Number of acute vulvovaginal candida infections
Timepoint [1] 431216 0
Monitored monthly post-treatment commencement for 6 months. This will be compared to the previous six months prior to the trial (information obtained through medical history at baseline interview).
Secondary outcome [2] 431217 0
Gastrointestinal symptoms and functional bowel health
Timepoint [2] 431217 0
Baseline and monthly for 6 months post-treatment commencement
Secondary outcome [3] 431218 0
Vulvar disease quality of life
Timepoint [3] 431218 0
Baseline and monthly for 6 months post-treatment commencement
Secondary outcome [4] 431219 0
Vaginal microbiome change in a subset of participants in each group
Timepoint [4] 431219 0
Baseline, 12 weeks, 24 weeks post-treatment commencement

Eligibility
Key inclusion criteria
- Females with medically diagnosed recurrent vulvovaginal candidiasis (RVVC); and gastrointestinal symptoms of candida overgrowth for a minimum of four weeks
- No serious current illnesses or specific chronic illness (per exclusion criteria)
- Participants must be on contraception, and those participants who choose to use hormonal contraception should be on stable levels at least 6 weeks prior to and during the trial
- Any prescription medication use by participants (other than that listed in exclusion criteria) must be stable for six weeks or more prior to trial
- Ability and willingness to collect vaginal swabs
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant, planning pregnancy or breastfeeding
- Not willing to use contraception for the duration of the study
- Taking warfarin or any other anti-coagulant medication, diabetic medication, corticosteroids, antibiotics, or immunosuppressive medications/treatments
- Diagnosed with cancer (if active within last five years and excepting skin cancer)
- Individuals diagnosed with significant chronic illness including inflammatory bowel disease, liver disorders, kidney disease, autoimmune disorders, pelvic inflammatory disease, cystitis, sexually transmitted infections (STI), or any other medically diagnosed vulvovaginal conditions (excepting RVVC)
- Treatment of any vaginal infection, STI or urinary tract infection within the last six weeks including the use of vaginal douches, pessaries, probiotics (including vaginal and oral administration) for any reason
- Use of corticosteroids or oral antibiotics for any condition within the last four weeks
- Use of any antifungal treatments regularly for control of RVVC, including medications (i.e., Nystatin or fluconazole) or herbal treatment (i.e., Pau D’arco or horopito). Probiotics are permissible providing the use is regular for four weeks or more and ongoing
- Currently unwell with acute infection or fever or having Covid-19 within the last four weeks
- In poor general health as assessed by Study Investigators

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/03/2024
Actual
Date of last participant enrolment
Anticipated
11/03/2025
Actual
Date of last data collection
Anticipated
11/09/2025
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 315706 0
Commercial sector/Industry
Name [1] 315706 0
Integria Healthcare (Australia) Pty Ltd.
Country [1] 315706 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Integria Healthcare (Australia) Pty Ltd.
Address
Country
Australia
Secondary sponsor category [1] 317813 0
None
Name [1] 317813 0
Address [1] 317813 0
Country [1] 317813 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314575 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 314575 0
https://niim.com.au/research/niim-human-research-ethics-committee
Ethics committee country [1] 314575 0
Australia
Date submitted for ethics approval [1] 314575 0
30/10/2023
Approval date [1] 314575 0
23/01/2024
Ethics approval number [1] 314575 0

Summary
Brief summary
The purpose of this study is to assess safety of internal eucalypt sap resin consumption and also to explore if a low dose taken over a period of six months may be able to decrease vulvo-vaginal candidiasis episodes and concurrent gastrointestinal symptoms in women with recurrent vulvo-vaginal candidiasis (RVVC) and gastrointestinal symptoms of microbial imbalance.
With the prevalence of RVVC and lack of safe long-term treatments for managing the symptoms of candida overgrowth (both gastrointestinal and vaginal), we are investigating this ingredient for potential in the management of RVVC alongside long-term safety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132058 0
Dr Elizabeth Steels
Address 132058 0
Integria Healthcare, Building 5, Freeway Office Park, 2728, Logan Rd, Eight Mile Plains QLD 4113
Country 132058 0
Australia
Phone 132058 0
+61 428983280
Fax 132058 0
Email 132058 0
elizabeth.steels@integria.com
Contact person for public queries
Name 132059 0
Elizabeth Steels
Address 132059 0
Integria Healthcare, Building 5, Freeway Office Park, 2728, Logan Rd, Eight Mile Plains QLD 4113
Country 132059 0
Australia
Phone 132059 0
+61 428983280
Fax 132059 0
Email 132059 0
elizabeth.steels@integria.com
Contact person for scientific queries
Name 132060 0
Elizabeth Steels
Address 132060 0
Integria Healthcare, Building 5, Freeway Office Park, 2728, Logan Rd, Eight Mile Plains QLD 4113
Country 132060 0
Australia
Phone 132060 0
+61 428983280
Fax 132060 0
Email 132060 0
elizabeth.steels@integria.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.