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CompletedNCT02628678Updated Aug 30, 2016

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

An interventional study of FOS in Healthy, sponsored by Kaleido Biosciences. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-30.

Sponsored by Kaleido Biosciences · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • Prebiotic
  • FOS
  • fructooligosaccharide
  • polyglycan
  • microbiome
  • microbiota
  • Healthy Volunteers
03

In context

Lead sponsor

Kaleido Biosciences is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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;
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Other
    Fructooligosaccharide (FOS)

    Subjects will be required to take 8 grams of FOS per day for a total of 10 days.

    Dietary Supplement: FOS

Interventions

  • Dietary supplementFOS
06

What researchers measure

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

07

Study locations

1 site
  • Kaleido Biosciences
    Cambridge, Massachusetts 02138, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02628678
Lead sponsor
Kaleido Biosciences
Responsible party
Sponsor
First posted
Dec 11, 2015
Start date
Nov 2015
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Aug 30, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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