Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers: A Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: L-Phenylalanine 500 mg Veg Capsule product.
- Who it may be relevant to
- Registry conditions: Gut Microbiome, Gut Health, Dietary Supplement, L-Phenylalanine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug L-Phenylalanine 500 mg Veg Capsule product
500 mg Veg Capsule product
Primary outcome measures
- Changes in phenylpropionic acid levels from baseline in subject fecal material [Time frame: Baseline, Week 2 (Day 14)]
- Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal material and swabs [Time frame: Baseline, Week 2 (Day 14)]
- Change in the number of T cells that react to fungal antigens from baseline in subject blood samples [Time frame: Baseline, Week 2 (Day 14)]
Secondary outcome measures (3)
- Change in phenylpropionic acid levels from baseline in subject fecal material [Time frame: Baseline, Week 4 (Day 28)]
- Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal material [Time frame: Baseline, Week 4 (Day 28)]
- Change in the number of T cells that react to fungal antigens from baseline in subject blood samples [Time frame: Baseline, Week 4 (Day 28)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Belfer Research Building — New York
Identifiers
NCT: NCT06433310 · 23-09026469