HealthyNCT04619875
A Clinical Study to Assess the Effect of Increasing Intake Amounts of Two Novel Glycans on the Gut Microbiota of Healthy Subjects
A study testing KB5, SG1 and Lactulose in people with Healthy, run by Kaleido Biosciences at 1 site in United States.
Trial summary
This exploratory, randomized, open label study aims to explore the safety, tolerability, pharmacokinetics, and effects of increasing intake amounts of two novel glycans on the gut microbiota of healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- KB5, SG1 and Lactulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2017to 21 Nov 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
To be eligible for inclusion, the patient must fulfill all of the following criteria at screening:
- Able and willing to provide informed consent
- Willing to provide multiple stool samples
- Be male or female, ≥18 and ≤65 years of age
- Have a body mass index ≥20 and <40 kg/m2
- No current renal, hepatic or metabolic disease, significant dyslipidemia, or infection.
- Willing to adhere to dietary requirements as stated in the protocol.
- Willing to continue his/her normal diet and exercise routine.
- Willing to continue taking any current supplements and vitamins, (with the exception of prebiotic or probiotic supplements) that the subject is currently taking, for the duration of the study.
- Negative urine drug screen
- If subject is female, have a negative urine pregnancy test at Screening and be willing to engage in method of contraception until completion of the study
Patients will be excluded from the study if they meet any of the following criteria at screening:
- Currently taking probiotic or prebiotic dietary supplements, or have taken them in the past 28 days (prior to Screening Visit), or unwilling to avoid probiotic or probiotic dietary supplements for the duration of the study
- Currently taking, or have taken in the last 7 days, drugs or other compounds to modulate gastrointestinal motility
- Recent history (within six weeks of Screening) of the following conditions requiring medical attention or treatment, including over-the-counter medications: constipation, diarrhea, and/or acute GI illness.
- Systemic antibiotics taken within the previous three months (prior to Screening Visit).
- History of or active inflammatory bowel disease
- History of or active irritable bowel syndrome
- History of or active autoimmune disease
- History of or active GI malignancy
- Established pre-diabetic status (eg, multiple fasting blood glucose measurements 100 to 125 mg/dL inclusive, or history of failed glucose tolerance tests) and as assessed by HbA1c test
- Have used an investigational drug or device within 30 dyas of study or be concurrently enrolled in another investigational drug or device study within 30 days of the study (prior to the Screening Visit)
- Subject is a current smoker
- Subject has a history of drug and/or alcohol abuse
- Contraindications, sensitivity, or known allergy to the use of the study product(s) or their components
- Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study (prior to the Screening Visit)
- Individuals who, in the opinion of the PI, are considered to be poor attendees or unlikely for any reason to be able to comply with the study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect of Increasing Intake Amounts of Two Novel Glycans on the Gut Microbiota of Healthy Subjects
This exploratory, randomized, open label study aims to explore the safety, tolerability, pharmacokinetics, and effects of increasing intake amounts of two novel glycans on the gut microbiota of healthy subjects.
- Conditions
- Healthy
- Being tested
- KB5, SG1, Lactulose
- Keywords
- Microbiome, Kaleido, Kaleido Biosciences, Oligosaccharide, Glycan, Microbiome Metabolic Therapy, KB174, KB5, SG1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KB5Other
KB5, a novel glycan, is a Kaleido laboratory code for KB174
SG1Other
SG1 is a novel glycan
LactuloseOther
Lactulose is a synthetic dissacharide
| Study group | Role | What they receive |
|---|---|---|
| Lactulose | Other | Not described Receives: Other: Lactulose |
| KB5 | Other | Not described Receives: Other: KB5 |
| SG1 | Other | Not described Receives: Other: SG1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by incidence of adverse advents
Measured: Day -8 to Day 35
Tolerability as assessed by Gastrointestinal Tolerability Questionnaire (GITQ) score
The GITQ is an assessment of the frequency and severity of GI symptoms, eg., gas, abdominal pain, calculated on a scale from 0 (None/Not applicable) to a maximum score of 60 (Severe/Much more than usual) for all questions
Measured: Day -8 to Day 35
Tolerability as assessed by change in Bristol Stool Scale (BSS)
The BSS is an assessment of stool consistency on a scale from 1 (separate hard lumps, like nuts, hard to pass) through 7 (watery, no solid pieces, entirely liquid)
Measured: Day -8 to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start11 Sep 2017
- Primary completion21 Nov 2017
- Study completion21 Nov 2017
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaleido Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Wingertzahn, PhD, Study director, Kaleido Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619875
- Sponsor's protocol ID
- K008-117
- Status last verified
- Nov 2020
- First submitted
- 26 Oct 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect of Increasing Intake Amounts of Two Novel Glycans on the Gut Microbiota of Healthy Subjects
- ClinicalTrials.gov ID
- NCT04619875
- Acronym / sponsor ID
- K008-117
- Conditions
- Healthy
- Keywords
- Microbiome, Kaleido, Kaleido Biosciences, Oligosaccharide, Glycan, Microbiome Metabolic Therapy, KB174, KB5
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Kaleido BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 21 Nov 2017 (actual)
- First posted
- 6 Nov 2020 (actual)
- 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.
This exploratory, randomized, open label study aims to explore the safety, tolerability, pharmacokinetics, and effects of increasing intake amounts of two novel glycans on the gut microbiota of healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lactulose | Other | Other: Lactulose |
| KB5 | Other | Other: KB5 |
| SG1 | Other | Other: SG1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| KB5KB5, a novel glycan, is a Kaleido laboratory code for KB174 | Other | KB5 |
| SG1SG1 is a novel glycan | Other | SG1 |
| LactuloseLactulose is a synthetic dissacharide | Other | Lactulose |
Primary outcome
Safety as assessed by incidence of adverse advents
Time frame: Day -8 to Day 35
Tolerability as assessed by Gastrointestinal Tolerability Questionnaire (GITQ) score
Time frame: Day -8 to Day 35
The GITQ is an assessment of the frequency and severity of GI symptoms, eg., gas, abdominal pain, calculated on a scale from 0 (None/Not applicable) to a maximum score of 60 (Severe/Much more than usual) for all questions
Tolerability as assessed by change in Bristol Stool Scale (BSS)
Time frame: Day -8 to Day 35
The BSS is an assessment of stool consistency on a scale from 1 (separate hard lumps, like nuts, hard to pass) through 7 (watery, no solid pieces, entirely liquid)
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 6 Nov 2020.
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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.
Mark Wingertzahn, PhD study director
Kaleido Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KB5, SG1 and Lactulose 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?
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 6 Nov 2020. 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?
Safety as assessed by incidence of adverse advents (time frame: Day -8 to Day 35). The study lists 3 primary outcomes in all. 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 6 Nov 2020.