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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Other: KB195
* Other: Polydextrose
* Other: Pullulan
* Other: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: KB195<br> | Other: KB195<br>* KB195 is a novel glycan<br>|
| Other: Polydextrose<br> | Other: Polydextrose<br>* Polydextrose is an oligosaccharide<br>|
| Other: Pullulan<br> | Other: Pullulan<br>* Pullulan is an oligosaccharide<br>|
| Other: Maltodextrin<br> | Other: Maltodextrin<br>* Maltodextrin is a digestible carbohydrate<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome, nitrogen metabolism, Kaleido, Kaleido Biosciences, KB195, Oligosaccharide, Glycan, Microbiome metabolic therapy, MMT