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

NCT04603378 | Completed

• 1 other identifier: K010-117
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

microbiome; nitrogen metabolism; Kaleido; Kaleido Biosciences; KB195; Oligosaccharide; Glycan; Microbiome metabolic therapy; MMT

Outcome Measures

Primary Outcomes (1)

• Number of patients experiencing any treatment-emergent adverse events (TEAEs)

  Day -8 to Day 29

Study Arms (4)

KB195

OTHER

Other: KB195

Polydextrose

OTHER

Other: Polydextrose

Pullulan

OTHER

Other: Pullulan

Maltodextrin

OTHER

Other: Maltodextrin

Interventions

KB195 OTHER

KB195 is a novel glycan

KB195

Polydextrose OTHER

Polydextrose is an oligosaccharide

Polydextrose

Pullulan OTHER

Pullulan is an oligosaccharide

Pullulan

Maltodextrin OTHER

Maltodextrin is a digestible carbohydrate

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Kaleido Biosciences: lead

Study Sites (1)

PPD Phase I Clinic

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

polydextrose; pullulan; maltodextrin

Study Officials

• Mark Wingertzahn, PhD

  Kaleido Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 26, 2020
• Study Start: September 18, 2017
• Primary Completion: November 28, 2017
• Study Completion: November 28, 2017
• Last Updated: October 26, 2020

Record last verified: 2020-10

Locations

US (1)