A Study to Evaluate the Effect of Diet on the Tolerability of FOS in Healthy Volunteers

Kaleido Biosciences

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: FOS

Study type

Interventional

Funder types

Industry

Identifiers

NCT02628678

G006-HU-PD

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Be able to give written informed consent;
Be male or female of any race, between 18 and 65 years of age;
Have a BMI > 20 & < 27 kg/m2;
Be willing to follow a controlled low fiber diet for a period of 11 days;

Exclusion criteria

Are less than 18 and greater than 65 years of age;
Are hypersensitive to any of the components of FOS;
Are currently taking probiotic or prebiotic supplements, or have taken them in the past 28 days;
Unwilling to avoid probiotics/prebiotics supplements for the duration of the study;
Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgment, entry to the study;
Subject is a smoker;
Subject has a history of drug and/or alcohol abuse at the time of enrollment;
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;
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;
Subjects may not be receiving treatment involving experimental drugs;
If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study;