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 range18 Years

SexALL

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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

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

Aurelia Li, MS

732-822-6836 aul4004@med.cornell.edu

View on ClinicalTrials.gov More Gut Microbiome trials