None listed
Conditions
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.
Interventions
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.
Sponsors
Integria Healthcare (Australia) Pty Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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
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
Outcome results
None listed