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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04603378
• Other study ID #: K010-117
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: November 28, 2017

Study information

• Verified date: October 2020
• Source: Kaleido Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 28, 2017
• Est. primary completion date: November 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• KB195
KB195 is a novel glycan
• Polydextrose
Polydextrose is an oligosaccharide
• Pullulan
Pullulan is an oligosaccharide
• Maltodextrin
Maltodextrin is a digestible carbohydrate

Locations

Country	Name	City	State
United States	PPD Phase I Clinic	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Kaleido Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients experiencing any treatment-emergent adverse events (TEAEs)		Day -8 to Day 29