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临床试验/NCT06433310
NCT06433310招募中4 期

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

Weill Medical College of Cornell University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年10月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
20
试验地点
2
主要终点
Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal material and swabs

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female adults over the age of 18 years

排除标准

  • 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

研究组 & 干预措施

Healthy

Experimental

Participants will receive one bottle of L-Phenylalanine 500 mg Veg Capsule product on Day 0. All subjects will be asked to start taking the supplement on Day 1 continuing until Day 14. They will be asked to take 2x 500 mg capsules in the morning and 1x 500 mg capsule in the evening daily for 14 days.

干预措施: L-Phenylalanine 500 mg Veg Capsule product (Drug)

结局指标

主要结局

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

时间窗: Baseline, 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.

Changes in phenylpropionic acid levels from baseline in subject fecal material

时间窗: Baseline, Week 2 (Day 14)

Metabolite phenylpropionic acid levels will be measured using mass spectrometry before (baseline) and after intervention

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

时间窗: Baseline, Week 2 (Day 14)

Blood will be processed through ELISA-based and in vitro restimulation assays to measure T cell reactivity to fungal antigens

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

时间窗: Baseline, 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.

次要结局

  • Change in phenylpropionic acid levels from baseline in subject fecal material(Baseline, Week 4 (Day 28))
  • Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal material(Baseline, Week 4 (Day 28))
  • Change in the number of T cells that react to fungal antigens from baseline in subject blood samples(Baseline, Week 4 (Day 28))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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