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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06433310
Enrollment
20
Registered
2024-05-29
Start date
2024-10-17
Completion date
2027-12-31
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Supplement, Gut Health, Gut Microbiome, L-Phenylalanine, Phenylpropionic Acid

Brief 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.

Detailed description

The human gastrointestinal tract hosts a diverse microbial community that has a role in influencing the host's pathophysiological responses. Although there is an abundance of metagenomic data available, the functional dynamics of the gut microbiota still need exploration in different conditions. The microbiota produces various metabolites from dietary products, impacting both host health and pathophysiological functions. The metabolites produced by different microbiota may selectively suppress or stimulate the growth of some components of the gut microbiome, ultimately influencing the dynamic of gut bacterial and fungal populations. Our lab is specifically interested in a metabolite, known as phenylpropionic acid (PPA) produced by a human gut resident bacteria known as Clostridium sporogenes. C. sporogenes produces PPA by metabolizing the amino acid, L-phenylalanine, which is sourced from human diet. Many studies have observed the antimicrobial and antifungal effects of PPA. Our lab determined PPA holds antifungal activity of PPA in the gut of mice colonized with Candida albicans. We are interested in investigating how diversity in the mycobiota populations, which focuses on the fungi species in the human gut, are related to changes in PPA levels. Therefore, this study will asses whether additional oral supplementation of L-phenylalanine has an effect on the way gut mycobiota responds to this amino acid. Healthy subjects received a 14-day supply of L-phenylalanine supplements and provided stool and blood samples to the study team.

Interventions

DRUGL-Phenylalanine 500 mg Veg Capsule product

500 mg Veg Capsule product

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in phenylpropionic acid levels from baseline in subject fecal materialBaseline, Week 2 (Day 14)Metabolite phenylpropionic acid levels will be measured using mass spectrometry before (baseline) and after intervention
Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal material and swabsBaseline, Week 2 (Day 14)Fungal populations, including Candida, will be measured using microbiota sequencing before (baseline) and after intervention. The most abundant fungal populations will be reported; however, the identity of those populations won't be known until sample analysis.
Change in the number of T cells that react to fungal antigens from baseline in subject blood samplesBaseline, Week 2 (Day 14)Blood will be processed through ELISA-based and in vitro restimulation assays to measure T cell reactivity to fungal antigens

Secondary

MeasureTime frameDescription
Change in phenylpropionic acid levels from baseline in subject fecal materialBaseline, Week 4 (Day 28)Metabolite phenylpropionic acid levels will be measured using mass spectrometry before (baseline) and after intervention
Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal materialBaseline, Week 4 (Day 28)Fungal populations, including Candida, will be measured using microbiota sequencing before (baseline) and after intervention. The most abundant fungal populations will be reported; however, the identity of those populations won't be known until sample analysis.
Change in the number of T cells that react to fungal antigens from baseline in subject blood samplesBaseline, Week 4 (Day 28)Blood will be processed through ELISA-based and in vitro restimulation assays to measure T cell reactivity to fungal antigens

Countries

United States

Contacts

CONTACTEmilia T Vignogna, BS
etv4001@med.cornell.edu505-259-4995
CONTACTTsering D Sherpa-Ngima, BSc
tss4002@med.cornell.edu929-328-9571
PRINCIPAL_INVESTIGATORIliyan D Iliev, PhD

Weill Medical College of Cornell University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026