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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04603378
Enrollment
47
Registered
2020-10-26
Start date
2017-09-18
Completion date
2017-11-28
Last updated
2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

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.

Interventions

OTHERKB195

KB195 is a novel glycan

Polydextrose is an oligosaccharide

OTHERPullulan

Pullulan is an oligosaccharide

OTHERMaltodextrin

Maltodextrin is a digestible carbohydrate

Sponsors

Kaleido Biosciences
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026