A Phase 1 interventional study of VE303 and Oral Vancomycin in Healthy Volunteers, sponsored by Vedanta Biosciences, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-27.
Sponsored by Vedanta Biosciences, Inc. · Phase 1, Interventional, and Other
This study was designed to evaluate safety and tolerability of a range of doses of VE303 in healthy adult volunteers. The study also evaluated pharmacokinetics of intestinal colonization by the VE303 strains and pharmacodynamics of recovery of the gut microbiota after administration of antibiotics followed by a course of VE303.
VE303 is a rationally-defined bacterial consortium candidate being developed for the prevention of recurrent C. difficile infection. VE303 consists of 8 types of clonal human commensal bacteria strains selected for their ability to provide colonization resistance to C. difficile and manufactured under GMP conditions.
Vedanta Biosciences, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Cohort 1 received oral vancomycin followed by a single dose of VE303.
Drug: VE303 · Drug: Oral Vancomycin
Cohort 2 received oral vancomycin followed by a single day of 5 doses of VE303.
Drug: VE303 · Drug: Oral Vancomycin
Cohort 3 received oral vancomycin followed by a single day of 10 doses of VE303.
Drug: VE303 · Drug: Oral Vancomycin
Cohort 4 received oral vancomycin followed by 5 days of 10 doses daily of VE303.
Drug: VE303 · Drug: Oral Vancomycin
Cohort 5 received oral vancomycin followed by 14 days of 10 capsules daily of VE303
Drug: VE303 · Drug: Oral Vancomycin
Cohort 6 received 21 days of 10 doses daily of VE303
Drug: VE303
Cohort 7 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days
Drug: VE303 · Drug: Oral Vancomycin
Cohort 8 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days
Drug: VE303 · Drug: Oral Vancomycin
Cohort 8 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days
Drug: VE303 · Drug: Oral Vancomycin
This cohort only received oral vancomycin.
Drug: Oral Vancomycin
The VE303 Drug Product is a live biotherapeutic product (LBP) consisting of 8 clonal human commensal bacterial strains manufactured under GMP conditions.
Vancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea.
Safety of VE303 measured by incidence adverse events (AEs)
Measured in terms of incidence of AEs according to CTCAE V4.0
Time frame: 12 months post-dose
Tolerability of VE303 using modified PROMIS questionnaire (v1.0)
Characterized the highest well tolerated dose regimen of VE303 using modified PROMIS questionnaire (v1.0)
Time frame: 12 months post-dose
Evaluate the colonization of the intestinal microbiota with VE303 component bacteria
Measurement of VE303 strain colonization in stool samples was performed using a metagenomic sequencing-based bioinformatic approach. A strain-specific marker panel was employed to characterize the relative abundance of VE303 strains in the intestinal microbiota.
Time frame: 12 months post-dose
Evaluate the changes in the intestinal microbiota due to VE303 dosing.
Measurement of intestinal microbiota due to VE303 dosing was performed using metagenomic sequencing- and metabolomic analysis-based approaches. Thus, focusing on taxonomic and functional changes occurring in the gut.
Time frame: 12 months post-dose
Evaluate the metabolomic changes in stool due to VE303 dosing.
Quantified changes in pool of metabolite levels (bile acids and short-chain fatty acids) from stool samples
Time frame: 12 months post-dose
Plan to share: No
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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Vedanta Biosciences, Inc.