A Study to Evaluate the Effect of Diet on the Tolerability of FOS in Healthy Volunteers
Completed · Not applicable
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT02628678
- Run by
- Kaleido Biosciences
- People needed
- 7
- Starts
- 2015-11-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2016-08-30
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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;
Where it is running
- Kaleido Biosciences — Cambridge, Massachusetts, United States
Full record on ClinicalTrials.gov
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