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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
Biofortis
Addison, Illinois, United States
Safety as assessed by incidence of adverse advents
Time frame: Day -8 to Day 35
Tolerability as assessed by Gastrointestinal Tolerability Questionnaire (GITQ) score
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
Time frame: Day -8 to Day 35
Tolerability as assessed by change in Bristol Stool Scale (BSS)
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)
Time frame: Day -8 to Day 35
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