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OpenTrials
Completed

NCT Number: NCT06146504

Clinical 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.

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Key information

Conditions

Candida Systemic Bacterial Infections and Mycoses Candida Albicans Infection Candida Infection Candidiasis Candidiasis, Invasive Infections Invasive Fungal Infections Mycoses

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.
  • Currently participating in any other clinical study.
  • History of substance abuse.
  • Unwilling to follow the study protocol.

Treatment and study plan

CanXida Remove (Formula RMV)

Dietary Supplement

Supplement composed of a 12 ingredient anti-fungal, anti-bacterial & anti-parasite formula.

Placebo

Other

Placebo product containing Dicalcium Phosphate, Magnesium Stearate, Stearic Acid, Croscarmellose Sodium, and Silica.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in vaginal health symptoms. [Timeframe: Baseline to Week 12]

    Time frame: 12 weeks

    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.

  2. Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS). [Timeframe: Baseline to Week 12]

    Time frame: 12 weeks

    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.

  3. Changes in scores on the Bristol Stool Scale. [Timeframe: Baseline to Week 12]

    Time frame: 12 weeks

    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.

  4. Changes in self-reported energy levels. [Timeframe: Baseline to Week 12]

    Time frame: 12 weeks

    Measured via study-specific questionnaires using a 5-point Likert scale. 0= the most favourable and 5= the least favourable response.

Sponsors and collaborators

Lead sponsor

CanXida

Industry

Collaborators

  • Citruslabs

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of an Anti-Fungal Supplement

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 24, 2023
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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