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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: KB195; Other: Polydextrose; Other: Pullulan; Other: Maltodextrin

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Phase I Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients experiencing any treatment-emergent adverse events (TEAEs)	Day -8 to Day 29

Collaborators and Investigators

• Sponsor: Kaleido Biosciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2017
• Primary Completion (ACTUAL): November 28, 2017
• Study Completion (ACTUAL): November 28, 2017

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (ACTUAL): October 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: microbiome; Kaleido; Kaleido Biosciences; Glycan; MMT; KB195; Oligosaccharide; nitrogen metabolism; Microbiome metabolic therapy
• Other Study ID Numbers: K010-117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No