A Randomized, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect of Increasing Intake Amounts of Two Novel Glycans on the Gut Microbiota of Healthy Subjects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Kaleido Biosciences
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Safety as assessed by incidence of adverse advents
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety as assessed by incidence of adverse advents
Time Frame: Day -8 to Day 35
Tolerability as assessed by change in Bristol Stool Scale (BSS)
Time Frame: 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
Time Frame: 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