Candida SystemicNCT06146504
Clinical Study to Evaluate the Efficacy of an Anti-Fungal Supplement
A study testing CanXida Remove (Formula RMV) in people with Candida Systemic and Candida Albicans Infection, run by CanXida at 1 site in United States.
Trial summary
This is a virtual, double-blind, two-arm, randomized, placebo-controlled clinical trial that will last 12 weeks. Participants will take the CanXida Remove Candida Cleansing Formula RMV or a placebo product daily and complete questionnaires at Baseline, Week 6, and Week 12. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Candida Systemic, Candida Albicans Infection, Candida Infection
- What is being tested?
- CanXida Remove (Formula RMV)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2023to 28 Jun 2024
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18-50.
- Female.
- Self-reported recurrent vaginal issues, including:
- Itching and irritation in and around the vaginal area.
- Burning sensation during urination or sexual intercourse.
- Abnormal discharge (e.g. thicker, white, and curd-like in appearance, odorless, or with a mild yeasty smell.
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- Redness and swelling of the vulva and surrounding skin
- Pain or discomfort in the vaginal area or lower abdomen.
- Urinary tract infections
- Vaginal thrush
- May also experience issues with fatigue, lethargy, and gut or digestive issues.
- Willing to provide two stool samples during the study.
- Willing to adhere to the study protocol.
- Willing to avoid introducing any products or any new forms of regular medication or supplements that target candida overgrowth, gut health, or vaginal health for the duration of the study.
Who cannot join
- Anyone with severe chronic conditions including oncological conditions, psychiatric disease, diabetes, or other.
- Anyone with known severe allergic reactions or is allergic to the test product or placebo ingredients.
- Currently taking any antibiotics or will be during the trial period.
- Anymore diagnosed with a sexually transmitted disease within the last three months e.g. Chlamydia, trichomoniasis, gonorrhea, genital herpes
- Women who are pregnant, breastfeeding, or attempting to become pregnant.
- Having any planned invasive medical procedures during the study period.
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- Currently participating in any other clinical study.
- History of substance abuse.
- Unwilling to follow the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of an Anti-Fungal Supplement
This is a virtual, double-blind, two-arm, randomized, placebo-controlled clinical trial that will last 12 weeks. Participants will take the CanXida Remove Candida Cleansing Formula RMV or a placebo product daily and complete questionnaires at Baseline, Week 6, and Week 12. Candida microbiome testing will be conducted via stool sample at Baseline and Week 12.
The participants will all be blinded to the name of the test brand.
- Being tested
- CanXida Remove (Formula RMV), Placebo
- Medical subject headings
- Candidiasis, Invasive, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanXida Remove (Formula RMV)Dietary supplement
Supplement composed of a 12 ingredient anti-fungal, anti-bacterial \& anti-parasite formula.
PlaceboOther
Placebo product containing Dicalcium Phosphate, Magnesium Stearate, Stearic Acid, Croscarmellose Sodium, and Silica.
| Study group | Role | What they receive |
|---|---|---|
| CanXida Supplement | Experimental | All participants will adhere to the following treatment regime:
Day 1-7: 1 tablet per day Day 8-22: 2 tablets per day Day 23- 84: 3 tablets per day
The product should always be taken with the first meal of the day. Receives: Dietary Supplement: CanXida Remove (Formula RMV) |
| Placebo | Placebo comparator | All participants will adhere to the following treatment regime:
Day 1-7: 1 tablet per day Day 8-22: 2 tablets per day Day 23- 84: 3 tablets per day
The product should always be taken with the first meal of the day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in growth of candida in the gut. [Timeframe: Baseline to Week 12]
Measured via gut microbiome analysis. Participants will provide a stool sample for the analysis.
Measured: 12 weeks
Secondary outcomes (4)
Changes in vaginal health symptoms. [Timeframe: Baseline to Week 12]
Measured via study-specific questionnaires. Questionnaires will use a Likert scale (0-5 scale) to measure changes in vaginal itching, vaginal discharge, vaginal discomfort. On the scale, 0= the least favourable score and 5= the most favourable score.
Measured: 12 weeks
Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS). [Timeframe: Baseline to Week 12]
The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Measured: 12 weeks
Changes in scores on the Bristol Stool Scale. [Timeframe: Baseline to Week 12]
The Bristol Stool Scale is a scale that classifies stools, ranging from the hardest to the softest. Experts consider types 1 and 2 to be uncharacteristically hard and indicative of constipation, while types 6 and 7 are unusually loose and may indicate diarrhea. Medical professionals generally consider types 3, 4, and 5 to be the most typical.
Measured: 12 weeks
Changes in self-reported energy levels. [Timeframe: Baseline to Week 12]
Measured via study-specific questionnaires using a 5-point Likert scale. 0= the most favourable and 5= the least favourable response.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start30 Nov 2023
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candida SystemicStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A = the intervention group Group B = the placebo group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CanXida
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146504
- Sponsor's protocol ID
- 20369
- Status last verified
- Aug 2024
- First submitted
- 19 Nov 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of an Anti-Fungal Supplement
- ClinicalTrials.gov ID
- NCT06146504
- Acronym / sponsor ID
- 20369
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CanXidaIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 24 Nov 2023 (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 is a virtual, double-blind, two-arm, randomized, placebo-controlled clinical trial that will last 12 weeks. Participants will take the CanXida Remove Candida Cleansing Formula RMV or a placebo product daily and complete questionnaires at Baseline, Week 6, and Week 12. Candida microbiome testing will be conducted via stool sample at Baseline and Week 12.
The participants will all be blinded to the name of the test brand.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Group A = the intervention group Group B = the placebo group
| Arm | Type | Receives |
|---|---|---|
| CanXida Supplement | Experimental | Dietary Supplement: CanXida Remove (Formula RMV)All participants will adhere to the following treatment regime: Day 1-7: 1 tablet per day Day 8-22: 2 tablets per day Day 23- 84: 3 tablets per day The product should always be taken with the first meal of the day. |
| Placebo | Placebo comparator | Other: PlaceboAll participants will adhere to the following treatment regime: Day 1-7: 1 tablet per day Day 8-22: 2 tablets per day Day 23- 84: 3 tablets per day The product should always be taken with the first meal of the day. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Aged between 18-50.
- Female.
- Self-reported recurrent vaginal issues, including:
- May also experience issues with fatigue, lethargy, and gut or digestive issues.
- Willing to provide two stool samples during the study.
Key exclusion criteria (9 listed)
- Anyone with severe chronic conditions including oncological conditions, psychiatric disease, diabetes, or other.
- Anyone with known severe allergic reactions or is allergic to the test product or placebo ingredients.
- Currently taking any antibiotics or will be during the trial period.
- Anymore diagnosed with a sexually transmitted disease within the last three months e.g. Chlamydia, trichomoniasis, gonorrhea, genital herpes
- Women who are pregnant, breastfeeding, or attempting to become pregnant.
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 |
|---|---|---|
| CanXida Remove (Formula RMV)Supplement composed of a 12 ingredient anti-fungal, anti-bacterial \& anti-parasite formula. | Dietary supplement | CanXida Supplement |
| PlaceboPlacebo product containing Dicalcium Phosphate, Magnesium Stearate, Stearic Acid, Croscarmellose Sodium, and Silica. | Other | Placebo |
Primary outcome
Changes in growth of candida in the gut. [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
Measured via gut microbiome analysis. Participants will provide a stool sample for the analysis.
4 secondary outcomes
Changes in vaginal health symptoms. [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS). [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
Changes in scores on the Bristol Stool Scale. [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
Changes in self-reported energy levels. [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
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 22 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CanXida Remove (Formula RMV) in people with Candida Systemic and Candida Albicans Infection, run by CanXida at 1 site in United States.
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 14 inclusion and 9 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 22 Aug 2024. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Changes in growth of candida in the gut. [Timeframe: Baseline to Week 12] (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2024.