Clinical trial NCT04603378: A Clinical Study to Assess the Effect of Novel Glycans on Nitrogen Metabolism of the Gut in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: microbiome
nitrogen metabolism
Kaleido
Kaleido Biosciences
KB195
Oligosaccharide
Glycan
Microbiome metabolic therapy
MMT
Lead sponsor: Kaleido Biosciences
Sponsor class: INDUSTRY
First posted: 2020-10-26
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Number of patients experiencing any treatment-emergent adverse events (TEAEs)
timeFrame: Day -8 to Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Phase I Clinic
state: Texas
Study officials:
affiliation: Kaleido Biosciences
name: Mark Wingertzahn, PhD
role: STUDY_DIRECTOR
References: