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

Candida Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06146504
• Other study ID #: 20369
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: February 2024
• Source: CanXida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Candida Albicans Infection
• Candida Infection
• Candidiasis
• Communicable Diseases
• Infections

Intervention

Dietary Supplement:
• CanXida Remove (Formula RMV)
Supplement composed of a 12 ingredient anti-fungal, anti-bacterial & anti-parasite formula.

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

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
CanXida	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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