Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433310
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-05-22
Brief Title:
Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers A Pilot Study
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 in fungal populations in the gut microbiome
Detailed Description:
The human gastrointestinal tract hosts a diverse microbial community that has a role in influencing the hosts 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 Csporogenes 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 the antifungal activity of PPA through decreased levels of Candida albicans in the mouse gut We are interested in investigating how diversity in mycobiota populations which focuses on the fungi species in the human gut are related to changes in PPA levels
Therefore this study will assess whether additional oral supplementation of L-Phenylalanine has any effect on the way C sporogenes metabolizes phenylalanine Healthy subjects will receive a 14-day supply of L-phenylalanine supplements and will provide stool and blood samples to the study team
Therefore this study will assess whether additional oral supplementation of L-Phenylalanine has any effect on the way C sporogenes metabolizes phenylalanine Healthy subjects will receive a 14-day supply of L-phenylalanine supplements and will provide stool and blood samples to the study team
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None