HealthyNCT02628678

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

A study testing FOS in people with Healthy, run by Kaleido Biosciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: FOS
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: Nov 2015to Dec 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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;

Who cannot join

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;

Show all 11Show fewer

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;

Trial locations and contacts

1 site in 1 country.

United States1 site

Kaleido Biosciences
Cambridge, Massachusetts, 02138

Other trials in United States

About this study

Official title: An Open-label Study to Evaluate the Effect of Diet on the Tolerability of FOS, a Commercially Available Prebiotic, 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.

Conditions: Healthy
Being tested: FOS
Keywords: Prebiotic, FOS, fructooligosaccharide, polyglycan, microbiome, microbiota, Healthy Volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FOSDietary supplement

Study groups in NCT02628678
Study group	Role	What they receive
Fructooligosaccharide (FOS)	Other	Subjects will be required to take 8 grams of FOS per day for a total of 10 days. Receives: Dietary Supplement: FOS

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of subjects with Adverse Events
Measured: 22 days

Secondary outcomes (1)

The effect of controlling diet on the tolerability of FOS by analyzing the gut microbiome
Measured: 22 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Dec 2015

First posted11 Dec 2015 (estimated)
Study startNov 2015
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02628678
Sponsor's protocol ID: G006-HU-PD
Status last verified: Aug 2016
First submitted: 2 Dec 2015
Last updated: 30 Aug 2016
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study to Evaluate the Effect of Diet on the Tolerability of FOS, a Commercially Available Prebiotic, in Healthy Volunteers
ClinicalTrials.gov ID: NCT02628678
Acronym / sponsor ID: G006-HU-PD
Conditions: Healthy
Keywords: Prebiotic, FOS, fructooligosaccharide, polyglycan, microbiome, microbiota, Healthy Volunteers
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Kaleido BiosciencesIndustry (pharma, biotech, devices)
Study start: Nov 2015
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 11 Dec 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Fructooligosaccharide (FOS)	Other	Dietary Supplement: FOSSubjects will be required to take 8 grams of FOS per day for a total of 10 days.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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;

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FOS	Dietary supplement	Fructooligosaccharide (FOS)

Primary outcome

Number of subjects with Adverse Events
Time frame: 22 days

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.

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Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FOS in people with Healthy, run by Kaleido Biosciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with Adverse Events (time frame: 22 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02628678.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016.