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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: FOS

• Registration Number: NCT02628678
• Lead Sponsor: Kaleido Biosciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-10
• Study First Posted: 2015-12-11
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fructooligosaccharide (FOS)	FOS	Subjects will be required to take 8 grams of FOS per day for a total of 10 days.

Primary Outcome Measures

Name	Time	Method
Number of subjects with Adverse Events	22 days

Secondary Outcome Measures

Name	Time	Method
The effect of controlling diet on the tolerability of FOS by analyzing the gut microbiome	22 days

Trial Locations

Locations (1)

Kaleido Biosciences; 🇺🇸 Cambridge, Massachusetts, United States