Clinical Study to Evaluate the Efficacy of an Anti-Fungal Supplement

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Candida Infection; Candida Albicans Infection; Candida Systemic
• Intervention / Treatment: Dietary supplement: CanXida Remove (Formula RMV); Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CanXida Supplement; 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.	Dietary supplement: CanXida Remove (Formula RMV); Supplement composed of a 12 ingredient anti-fungal, anti-bacterial & anti-parasite formula.
Placebo Comparator: Placebo; 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.	Other: Placebo; Placebo product containing Dicalcium Phosphate, Magnesium Stearate, Stearic Acid, Croscarmellose Sodium, and Silica.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks
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.	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.	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.	12 weeks

Collaborators and Investigators

• Sponsor: CanXida
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: November 19, 2023
• First Submitted That Met QC Criteria: November 19, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Mycoses; Infections; Communicable Diseases; Candidiasis
• Other Study ID Numbers: 20369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No