A Clinical Study to Assess the Effect of Novel Glycans on Nitrogen Metabolism of the Gut in Healthy Subjects

Sponsor

Kaleido Biosciences (Industry)

Overall Status

Completed

CT.gov ID

NCT04603378

Collaborator

(none)

Enrollment

Location

Arms

2.3

Actual Duration (Months)

20.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This exploratory, randomized, double-blind, placebo-controlled study aims to explore the effect of novel glycans on nitrogen metabolism in the gut in healthy subjects using a stable isotope.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: KB195 Other: Polydextrose Other: Pullulan Other: Maltodextrin	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Novel Glycans on Nitrogen Metabolism of the Gut in Healthy Subjects Using a Stable Isotope

Actual Study Start Date :

Sep 18, 2017

Actual Primary Completion Date :

Nov 28, 2017

Actual Study Completion Date :

Nov 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: KB195	Other: KB195 KB195 is a novel glycan
Other: Polydextrose	Other: Polydextrose Polydextrose is an oligosaccharide
Other: Pullulan	Other: Pullulan Pullulan is an oligosaccharide
Other: Maltodextrin	Other: Maltodextrin Maltodextrin is a digestible carbohydrate

Outcome Measures

Primary Outcome Measures

Number of patients experiencing any treatment-emergent adverse events (TEAEs) [Day -8 to Day 29]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 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:

Willing to provide multiple stool samples
Be male or female, ≥18 and <50 years of age
Have a body mass index ≥18 and <50 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 usual 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

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 prebiotic or probiotic dietary supplements for the duration of the study
Currently taking, or have taken during the last seven days prior to enrollment, drugs or other compounds that modulate GI motility
Currently taking bismuth, or have taken bismuth within seven days prior to enrollment
Recent history (within six weeks of Screening Visit) of the following condition 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.