HealthyNCT02628652
Study to Evaluate the Tolerability of Prebiotics on the Microbiota
A study testing GOS, GLOS and FOS in people with Healthy, run by Kaleido Biosciences at 1 site in Ireland.
Trial summary
The primary objective of this study is to determine the tolerability of two polyglycan food ingredients, GOS and GLOS, at two different levels in healthy human subjects. The comparator in this study will be Inulin FOS, a commercially available glycan supplement. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GOS, GLOS and FOS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIreland
- Study dates
- Oct 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be able to give written informed consent,
- Be male or female, between 18 and 40 years of age,
- Have a BMI ≥ 20 \& ≤ 27 kg/m2,
- Be a non-pregnant female,
- Be in generally good health,
- Subjects will continue on his/her normal diet and exercise routine,
- Be an Irish National.
Who cannot join
- Are less than 18 and greater than 40 years of age,
- Females are pregnant, lactating or wish to become pregnant during the study. Female subject is currently either of:
- non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or any female who is surgically sterilized (via documented hysterectomy or bilateral tubal ligation). (For purposes of this study, postmenopausal is defined as one year without menses), OR
- child bearing potential, the subject is eligible to enter and participate in this study if she is not lactating and has a negative urine pregnancy test at the screening visit, visit 2 and upon completion of the study at visit 7. The subject must also agree to one of the following methods of contraception: i. Complete abstinence from intercourse two weeks prior to administration of study, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study medication in cases where subject discontinues the study prematurely. (Subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit.) or, ii. has a male sexual partner who is surgically sterilized prior to the Screen Visit and is the only male sexual partner for that subject or, iii. sexual partner(s) is of the same gender or, iv. Oral or implant contraceptives (either combined or progestogen only) with double-barrier method of contraception consisting of spermicide with either condom or diaphragm. (Women of child-bearing potential using an oral contraceptive in combination with a double-barrier method of contraception are required to continue to use this form of contraception for 1 week following discontinuation of study medication) or, v. Use of double-barrier contraception, specifically, a spermicide plus a mechanical barrier (e.g. male condom, female diaphragm). The subject must be using this method for at least 1 week following the end of the study or, vi. Use of any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year. The subject must have the device inserted at least 2 weeks prior to the first Screen Visit, throughout the study, and 2 weeks following the end of the study.
- Are hypersensitive to any of the components of the test product,
- Are currently taking probiotic or prebiotic supplements, or have taken them in the past 28 days,
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- Unwilling to avoid probiotics/prebiotics supplements for the duration of the study
- Subject has taken antibiotics in the previous 3 months,
- Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgement, entry to the study,
- Subject is a smoker,
- Subject has a history of drug and/or alcohol abuse at the time of enrolment,
- Having a condition or have 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,
- Have a malignant disease or any concomitant end-stage organ disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single-Blind, Controlled Study to Evaluate the Tolerability of Prebiotics on the Microbiota
The primary objective of this study is to determine the tolerability of two polyglycan food ingredients, GOS and GLOS, at two different levels in healthy human subjects. The comparator in this study will be Inulin FOS, a commercially available glycan supplement.
- Conditions
- Healthy
- Being tested
- GOS, GLOS, FOS
- Keywords
- Microbiome, FOS, polyglycan, prebiotic, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GOSDietary supplement
GLOSDietary supplement
FOSDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Gluco-Galacto-Oligosaccharide (GOS) | Experimental | Subjects randomized to this treatment arm will ingest GOS once per day for a total of 14 days. One level of GOS will be taken during Phase I and 2 levels of GOS will be taken during Phase II. Receives: Dietary Supplement: GOS |
| Gluco-Oligosaccharide (GLOS) | Experimental | Subjects randomized to this treatment arm will ingest GLOS once per day for a total of 14 days. One level of GLOS will be taken during Phase I and 2 levels of GLOS will be taken during Phase II. Receives: Dietary Supplement: GLOS |
| FructoOligosaccharide (FOS) | Active comparator | Subjects randomized to this treatment arm will ingest FOS once per day for a total of 14 days. One level of FOS will be taken during Phase I and 2 levels of FOS will be taken during Phase II. 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 in each group
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startOct 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaleido Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628652
- Sponsor's protocol ID
- AFCRO-057
- Status last verified
- Feb 2016
- First submitted
- 2 Dec 2015
- Last updated
- 24 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-Blind, Controlled Study to Evaluate the Tolerability of Prebiotics on the Microbiota
- ClinicalTrials.gov ID
- NCT02628652
- Acronym / sponsor ID
- AFCRO-057
- Conditions
- Healthy
- Keywords
- Microbiome, FOS, polyglycan, prebiotic, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kaleido BiosciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 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 tolerability of two polyglycan food ingredients, GOS and GLOS, at two different levels in healthy human subjects. The comparator in this study will be Inulin FOS, a commercially available glycan supplement.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gluco-Galacto-Oligosaccharide (GOS) | Experimental | Dietary Supplement: GOSSubjects randomized to this treatment arm will ingest GOS once per day for a total of 14 days. One level of GOS will be taken during Phase I and 2 levels of GOS will be taken during Phase II. |
| Gluco-Oligosaccharide (GLOS) | Experimental | Dietary Supplement: GLOSSubjects randomized to this treatment arm will ingest GLOS once per day for a total of 14 days. One level of GLOS will be taken during Phase I and 2 levels of GLOS will be taken during Phase II. |
| FructoOligosaccharide (FOS) | Active comparator | Dietary Supplement: FOSSubjects randomized to this treatment arm will ingest FOS once per day for a total of 14 days. One level of FOS will be taken during Phase I and 2 levels of FOS will be taken during Phase II. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Be able to give written informed consent,
- Be male or female, between 18 and 40 years of age,
- Have a BMI ≥ 20 \& ≤ 27 kg/m2,
- Be a non-pregnant female,
- Be in generally good health,
Key exclusion criteria (16 listed)
- Are less than 18 and greater than 40 years of age,
- Females are pregnant, lactating or wish to become pregnant during the study. Female subject is currently either of:
- Are hypersensitive to any of the components of the test product,
- 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
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 |
|---|---|---|
| GOS | Dietary supplement | Gluco-Galacto-Oligosaccharide (GOS) |
| GLOS | Dietary supplement | Gluco-Oligosaccharide (GLOS) |
| FOS | Dietary supplement | FructoOligosaccharide (FOS) |
Primary outcome
Number of subjects with Adverse Events in each group
Time frame: 28 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 24 Feb 2016.
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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 GOS, GLOS and FOS in people with Healthy, run by Kaleido Biosciences at 1 site in Ireland.
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 7 inclusion and 16 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 24 Feb 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 Ireland. 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 in each group (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2016.