Clinical trial NCT06146504: Clinical Study to Evaluate the Efficacy of an Anti-Fungal Supplement
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of an Anti-Fungal Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Candida Systemic
Candida Albicans Infection
Candida Infection
Lead sponsor: CanXida
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-11-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A = the intervention group Group B = the placebo group
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Aged between 18-50.
2. Female.
3. 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.
   * Redness and swelling of the vulva and surrounding skin
   * Pain or discomfort in the vaginal area or lower abdomen.
   * Urinary tract infections
   * Vaginal thrush
4. May also experience issues with fatigue, lethargy, and gut or digestive issues.
5. Willing to provide two stool samples during the study.
6. Willing to adhere to the study protocol.
7. 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.

Exclusion Criteria:

1. Anyone with severe chronic conditions including oncological conditions, psychiatric disease, diabetes, or other.
2. Anyone with known severe allergic reactions or is allergic to the test product or placebo ingredients.
3. Currently taking any antibiotics or will be during the trial period.
4. Anymore diagnosed with a sexually transmitted disease within the last three months e.g. Chlamydia, trichomoniasis, gonorrhea, genital herpes
5. Women who are pregnant, breastfeeding, or attempting to become pregnant.
6. Having any planned invasive medical procedures during the study period.
7. Currently participating in any other clinical study.
8. History of substance abuse.
9. Unwilling to follow the study protocol.

Primary outcomes:
measure: Changes in growth of candida in the gut. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in vaginal health symptoms. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS). [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in scores on the Bristol Stool Scale. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in self-reported energy levels. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: