Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614166
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Food Trial to Evaluate the Kinetics of the Medical Foods SBD111 and SBD121 Persistence in Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Food Trial to Evaluate the Kinetics of the Medical Foods SBD111 and SBD121 Persistence in Healthy Adults
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a randomized open-label trial in healthy volunteers Trial participants will be given a medical food product combination of probiotics and prebiotics called SBD111 or SBD121 for seven days and microbial abundance in feces will be measured during that time and for four weeks following administration
Detailed Description:
This DMA persistence food trial provides critical complimentary data to the ongoing efficacy food trials of SBD111 and SBD121 medical foods While the SBD111 and SBD121 medical food products have been tested in multiple preclinical studies GLP-Toxicity studies in Rats and ongoing safety and efficacy trials no study has yet examined how quickly these DMAs become detectableactive in human stool samples or the rate they clear from human stool following treatment cessation The data provided by this study could inform the interpretation efficacy trial data with regard to subject adherence
Objectives The primary goal of this study is to evaluate the prevalence and persistence of SBD111 and SBD121 medical foods two novel combinations of probiotics and prebiotic dietary fibers over time in stool samples We will determine the effect of these Defined Microbial Assemblages DMAs on fecal microbiota composition and functional potential as well as the duration of SBD111 and SBD121 product persistence in the gastrointestinal tract DMAs will be administered for 7 days and stool samples will be collected during DMA administration and up to 28 days post DMA cessation for microbial DNA extraction Fecal microbial DNA will be subjected to qPCR and high throughput shotgun sequencing to determine the presence and amount of DMA microbes that are present before during and after DMA administration We will also use the resulting shotgun sequencing data to determine whether any taxonomic shifts or functional changes occur in response to DMA administration andor cessation Finally as an exploratory measure we will attempt to isolate live DMA microbes from participants fecal samples using microbiological techniques
Objectives The primary goal of this study is to evaluate the prevalence and persistence of SBD111 and SBD121 medical foods two novel combinations of probiotics and prebiotic dietary fibers over time in stool samples We will determine the effect of these Defined Microbial Assemblages DMAs on fecal microbiota composition and functional potential as well as the duration of SBD111 and SBD121 product persistence in the gastrointestinal tract DMAs will be administered for 7 days and stool samples will be collected during DMA administration and up to 28 days post DMA cessation for microbial DNA extraction Fecal microbial DNA will be subjected to qPCR and high throughput shotgun sequencing to determine the presence and amount of DMA microbes that are present before during and after DMA administration We will also use the resulting shotgun sequencing data to determine whether any taxonomic shifts or functional changes occur in response to DMA administration andor cessation Finally as an exploratory measure we will attempt to isolate live DMA microbes from participants fecal samples using microbiological techniques
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None