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

NCT06146504 | Completed

• 1 other identifier: 20369
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Candida Systemic; Candida Albicans Infection; Candida Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  12 weeks

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

  12 weeks

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

  12 weeks

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

  12 weeks

Study Arms (2)

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.

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.

Other: Placebo

Interventions

CanXida Remove (Formula RMV) DIETARY_SUPPLEMENT

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

CanXida Supplement

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CanXida: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Candidiasis, Invasive; Candidiasis

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This study will be double-blinded in that the study participants and the Citruslabs team will be blinded to the intervention or product allocation. Only the sponsor will know which product contains the active ingredients. After the study analysis is complete, the allocation will be unblinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Group A = the intervention group Group B = the placebo group

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 24, 2023
• Study Start: November 30, 2023
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

US (1)