RecruitingPhase 4

Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers: A Pilot Study

United States20 participantsStarted 2024-10-17

Plain-language summary

The purpose of this study is to explore how the dietary supplement L-Phenylalanine affects the production of the metabolite phenylpropionic acid (PPA) and changes fungal populations of the gut microbiome.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female adults over the age of 18 years Exclusion Criteria: * History of a diagnosis of any gastrointestinal condition, such as inflammatory bowel syndrome or disease * Antibiotic usage within the past two weeks * Antifungal usage within the past month * Allergy to L-Phenylalanine or individuals with phenylketonuria (PKU) * Adults taking medications known to interact with L-phenylalanine supplements, such as Monoamine Oxidase Inhibitors (MOAI), L-DOPA, and some antipsychotic drugs (complete and extensive drug list will be provided to interested participants during screening) * Pregnant or nursing women

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in phenylpropionic acid levels from baseline in subject fecal material

Timeframe: Baseline, Week 2 (Day 14)

Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal material and swabs

Timeframe: Baseline, Week 2 (Day 14)

Change in the number of T cells that react to fungal antigens from baseline in subject blood samples

Timeframe: Baseline, Week 2 (Day 14)

Trial details

NCT IDNCT06433310

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-17

Contact for this trial

Emilia T Vignogna, BS

505-259-4995 etv4001@med.cornell.edu

View on ClinicalTrials.gov More Gut Microbiome trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in phenylpropionic acid levels from baseline in subject fecal material

Timeframe: Baseline, Week 2 (Day 14)

Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal material and swabs

Timeframe: Baseline, Week 2 (Day 14)

Change in the number of T cells that react to fungal antigens from baseline in subject blood samples

Timeframe: Baseline, Week 2 (Day 14)