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A Clinical Study to Assess the Effect of Increasing Intake Amounts of Two Novel Glycans on the Gut Microbiota of Healthy Subjects

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04619875
Enrollment
36
Registered
2020-11-06
Start date
2017-09-11
Completion date
2017-11-21
Last updated
2020-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Microbiome, Kaleido, Kaleido Biosciences, Oligosaccharide, Glycan, Microbiome Metabolic Therapy, KB174, KB5, SG1

Brief 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.

Interventions

OTHERKB5

KB5, a novel glycan, is a Kaleido laboratory code for KB174

OTHERSG1

SG1 is a novel glycan

OTHERLactulose

Lactulose is a synthetic dissacharide

Sponsors

Kaleido Biosciences
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Safety as assessed by incidence of adverse adventsDay -8 to Day 35
Tolerability as assessed by Gastrointestinal Tolerability Questionnaire (GITQ) scoreDay -8 to Day 35The 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)Day -8 to Day 35The 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026