A Clinical Study to Assess the Effect of Novel Glycans on Nitrogen Metabolism of the Gut in Healthy Subjects

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Pullulan; Other: Maltodextrin; Other: KB195; Other: Polydextrose

• Registration Number: NCT04603378
• Lead Sponsor: Kaleido Biosciences

Brief Summary

This exploratory, randomized, double-blind, placebo-controlled study aims to explore the effect of novel glycans on nitrogen metabolism in the gut in healthy subjects using a stable isotope.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-18
• Primary Completion: 2017-11-28
• Study Completion: 2017-11-28
• Status Verified: 2020-10
• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-21
• Last Update Submitted: 2020-10-21
• Study First Posted: 2020-10-26
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pullulan	Pullulan	-
Maltodextrin	Maltodextrin	-
KB195	KB195	-
Polydextrose	Polydextrose	-

Primary Outcome Measures

Name	Time	Method
Number of patients experiencing any treatment-emergent adverse events (TEAEs)	Day -8 to Day 29

Trial Locations

Locations (1)

PPD Phase I Clinic; 🇺🇸 Austin, Texas, United States