A Clinical Study to Assess the Effect of Increasing Intake Amounts of Two Novel Glycans on the Gut Microbiota of Healthy Subjects

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: KB5; Other: Lactulose; Other: SG1

• Registration Number: NCT04619875
• Lead Sponsor: Kaleido Biosciences

Brief Summary

This exploratory, randomized, open label study aims to explore the safety, tolerability, pharmacokinetics, and effects of increasing intake amounts of two novel glycans on the gut microbiota of healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-11
• Primary Completion: 2017-11-21
• Study Completion: 2017-11-21
• Study First Submitted: 2020-10-26
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-03
• Last Update Submitted: 2020-11-03
• Study First Posted: 2020-11-06
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KB5	KB5	-
Lactulose	Lactulose	-
SG1	SG1	-

Primary Outcome Measures

Name	Time	Method
Safety as assessed by incidence of adverse advents	Day -8 to Day 35
Tolerability as assessed by change in Bristol Stool Scale (BSS)	Day -8 to Day 35	The BSS is an assessment of stool consistency on a scale from 1 (separate hard lumps, like nuts, hard to pass) through 7 (watery, no solid pieces, entirely liquid)
Tolerability as assessed by Gastrointestinal Tolerability Questionnaire (GITQ) score	Day -8 to Day 35	The GITQ is an assessment of the frequency and severity of GI symptoms, eg., gas, abdominal pain, calculated on a scale from 0 (None/Not applicable) to a maximum score of 60 (Severe/Much more than usual) for all questions

Trial Locations

Locations (1)

Biofortis; 🇺🇸 Addison, Illinois, United States