Healthy
Conditions
Keywords
Prebiotic, FOS, fructooligosaccharide, polyglycan, microbiome, microbiota, Healthy Volunteers
Brief summary
The primary objective of this study is to determine the 5-day tolerability of one commercially available prebiotic food ingredient, FOS, in healthy human subjects with and without diet control.
Interventions
DIETARY_SUPPLEMENTFOS
Sponsors
Kaleido Biosciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Be able to give written informed consent; 2. Be male or female of any race, between 18 and 65 years of age; 3. Have a BMI \> 20 & \< 27 kg/m2; 4. Be willing to follow a controlled low fiber diet for a period of 11 days;
Exclusion criteria
1. Are less than 18 and greater than 65 years of age; 2. Are hypersensitive to any of the components of FOS; 3. Are currently taking probiotic or prebiotic supplements, or have taken them in the past 28 days; 4. Unwilling to avoid probiotics/prebiotics supplements for the duration of the study; 5. Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgment, entry to the study; 6. Subject is a smoker; 7. Subject has a history of drug and/or alcohol abuse at the time of enrollment; 8. Taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; 9. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial; 10. Subjects may not be receiving treatment involving experimental drugs; 11. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with Adverse Events | 22 days |
Secondary
| Measure | Time frame |
|---|---|
| The effect of controlling diet on the tolerability of FOS by analyzing the gut microbiome | 22 days |
Other
| Measure | Time frame |
|---|---|
| The effect of FOS on each subject's gut microbiome | 22 days |
Countries
United States
Outcome results
None listed