Study Description:
This is a single-site, single-arm, open-label study to evaluate the effect of bismuth subsalicylate (BSS) on the human gut microbiome and host immune response. Upon confirmation of eligibility, healthy adult volunteers will provide stool and optional blood, saliva, urine, and intestinal biopsy samples for a baseline assessment of gut microbiome and host immune response. Up to 18 weeks later, participants will undergo a 2-day/8-dose regimen of oral BSS. Stool will be collected at baseline, days 2 (+3), 8 (+/-3), 14 (-3/+7) and 28 (+/-7). Blood, saliva, and urine are also optional at these time points. Participants may also undergo a second optional colonoscopy at day 8 (+/-3) to provide colon biopsies for research analysis.
Primary Objective:
To evaluate the effect of BSS on the human gut microbiome.
Secondary Objective:
To evaluate the effect of BSS on the human gut metabolome.
Tertiary/Exploratory Objective:
To evaluate the effect of BSS on the systemic and intestinal host response (immune and inflammatory responses).
Primary Endpoint:
Differences in the relative abundance of taxa in stool samples pre-BSS and approximately 1 month post-BSS. Differences in microbiome metrics of alpha diversity and beta diversity will also be assessed.
Secondary Endpoint:
Differences in the stool metabolome (including short chain fatty acids, bile acids, and untargeted metabolomics) pre-BSS and approximately 1 month post-BSS.
Tertiary/Exploratory Endpoint:
Differences in systemic host immune and inflammatory responses, such as cytokines and immune cells, and host intestinal immune responses, such as specific T-cell populations in intestinal biopsies pre-BSS and approximately 1 month post-BSS.
This is a single-site, single-arm, open-label study to evaluate the effect of bismuth subsalicylate (BSS) on the human gut microbiome and host immune response. Upon confirmation of eligibility, healthy adult volunteers will provide stool and optional blood, saliva, urine, and intestinal biopsy samples for a baseline assessment of gut microbiome and host immune response. Up to 18 weeks later, participants will undergo a 2-day/8-dose regimen of oral BSS. Stool will be collected at baseline, days 2 (+3), 8 (+/-3), 14 (-3/+7) and 28 (+/-7). Blood, saliva, and urine are also optional at these time points. Participants may also undergo a second optional colonoscopy at day 8 (+/-3) to provide colon biopsies for research analysis.
Primary Objective:
To evaluate the effect of BSS on the human gut microbiome.
Secondary Objective:
To evaluate the effect of BSS on the human gut metabolome.
Tertiary/Exploratory Objective:
To evaluate the effect of BSS on the systemic and intestinal host response (immune and inflammatory responses).
Primary Endpoint:
Differences in the relative abundance of taxa in stool samples pre-BSS and approximately 1 month post-BSS. Differences in microbiome metrics of alpha diversity and beta diversity will also be assessed.
Secondary Endpoint:
Differences in the stool metabolome (including short chain fatty acids, bile acids, and untargeted metabolomics) pre-BSS and approximately 1 month post-BSS.
Tertiary/Exploratory Endpoint:
Differences in systemic host immune and inflammatory responses, such as cytokines and immune cells, and host intestinal immune responses, such as specific T-cell populations in intestinal biopsies pre-BSS and approximately 1 month post-BSS.
Visit ClinicalTrials.gov for details.
Contact Information
Office/Contact: NIH Clinical Center Office of Patient Recruitment (OPR)
Phone: 800-411-1222
TTY: TTY dial 711
Email: ccopr@nih.gov