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

NCT ID: NCT04619875

Last Updated: 2020-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-11
• Study Completion Date: 2017-11-21

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.

Conditions

Healthy

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Lactulose

Group Type: OTHER

Lactulose

Intervention Type: OTHER

Lactulose is a synthetic dissacharide

KB5

Group Type: OTHER

KB5

Intervention Type: OTHER

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

SG1

Group Type: OTHER

SG1

Intervention Type: OTHER

SG1 is a novel glycan

Interventions

KB5

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

Intervention Type: OTHER

SG1

SG1 is a novel glycan

Intervention Type: OTHER

Lactulose

Lactulose is a synthetic dissacharide

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaleido Biosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Wingertzahn, PhD

Role: STUDY_DIRECTOR

Kaleido Biosciences

Locations

Biofortis

Addison, Illinois, United States

Countries

United States

Other Identifiers

K008-117

Identifier Type: -

Identifier Source: org_study_id