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OpenTrials
Completed

NCT Number: NCT02628678

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaleido Biosciences

Cambridge, Massachusetts, 02138, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

FOS

Dietary Supplement

Primary outcomes

  1. Number of subjects with Adverse Events

    Time frame: 22 days

Secondary outcomes

  1. The effect of controlling diet on the tolerability of FOS by analyzing the gut microbiome

    Time frame: 22 days

Other outcomes

  1. The effect of FOS on each subject's gut microbiome

    Time frame: 22 days

Sponsors and collaborators

Lead sponsor

Kaleido Biosciences

Industry

Registry information

Official study title

An Open-label Study to Evaluate the Effect of Diet on the Tolerability of FOS, a Commercially Available Prebiotic, in Healthy Volunteers

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 11, 2015
Registry last updated
Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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