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

Sponsor

Kaleido Biosciences (Industry)

Overall Status

Completed

CT.gov ID

NCT04619875

Collaborator

(none)

Enrollment

Location

Arms

2.3

Actual Duration (Months)

15.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: KB5 Other: SG1 Other: Lactulose	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Sep 11, 2017

Actual Primary Completion Date :

Nov 21, 2017

Actual Study Completion Date :

Nov 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Lactulose	Other: Lactulose Lactulose is a synthetic dissacharide
Other: KB5	Other: KB5 KB5, a novel glycan, is a Kaleido laboratory code for KB174
Other: SG1	Other: SG1 SG1 is a novel glycan

Arm

Intervention/Treatment

Other: Lactulose

Other: Lactulose

Lactulose is a synthetic dissacharide

Other: KB5

Other: KB5

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

Other: SG1

Other: SG1

SG1 is a novel glycan

Outcome Measures

Primary Outcome Measures

Safety as assessed by incidence of adverse advents [Day -8 to Day 35]
Tolerability as assessed by Gastrointestinal Tolerability Questionnaire (GITQ) score [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) [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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