Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis

Early Cirrhosis Clinical Trial

Official title:

A Randomized, Double-blind, Controlled, Clinical Food Study to Evaluate the Effect of KB174 Compared to an Easily Digestible Polysaccharide on Function and Structure of the Gut Microbiome in Subjects With Well-compensated Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03855956
• Other study ID #: K022-118
• Status: Completed
• Phase: N/A
• Start date: February 27, 2019
• Est. completion date: October 1, 2019

Study information

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

Clinical Trial Summary

This randomized, double-blind, controlled, clinical food study aims to explore KB174, a novel mixture of oligosaccharides, and maltodextrin, an easily digestible polysaccharide, on gut microbiome structure and function in subjects with well-compensated cirrhosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Be able and willing to provide written informed consent

• Be male or female, 18 to 70 years of age (inclusive)

• Have a body mass index (BMI) = 20.0 and < 40.0 kg/m2

• Well-compensated cirrhosis

• Negative for hepatocellular carcinoma (HCC)

• Adequate safety laboratory values at Screening.

• Be willing to maintain a stable diet throughout the course of the study, and willing to continue usual exercise routine

• If of child bearing potential must follow contraceptive requirements of the protocol

• Have reliable internet access

Exclusion Criteria:

• Have evidence of decompensated liver disease.

• History or active GI disease.

• Prior solid organ transplantation, including liver transplantation or on liver transplant waiting list.

• Subject has a history of drug and/or alcohol abuse.

Related Conditions & MeSH terms

• Early Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

Other:
• KB174
KB174 is a novel mixture of oligosaccharides.
• Maltodextrin
Maltodextrin is a commercially available easily digestible polysaccharide.

Locations

Country	Name	City	State
United States	Research Centers of America	Hollywood	Florida
United States	Advanced Pharma CR, LLC	Miami	Florida
United States	Delta Research Partners	Monroe	Louisiana
United States	Marquez Clinical Site Partners, LLC Florida Premier Research Institute	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Kaleido Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 15N in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.	Change in 15N in urine in response to an amino acid challenge during Baseline (pre-study compound consumption) versus post-28-day study compound compound consumption.	Day -3 to Day 28.
Secondary	Change in 15N in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.	Change in 15N in stool in response to an amino acid challenge during Baseline (pre-study compound consumption) versus post 28-day study compound consumption.	Day -3 to Day 29.
Secondary	Change in total nitrogen in blood in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.	Change in total nitrogen in blood in response to an amino acid challenge during Baseline [pre-study compound consumption] versus post 28-day study compound consumption.	Day -3 to Day 27.
Secondary	Change in total nitrogen in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.	Change in total nitrogen in urine in response to an amino acid challenge during Baseline [pre study compound consumption] versus post 28-day study compound consumption.	Day -3 to Day 29.
Secondary	. Change in total nitrogen in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.	Change in total nitrogen in stool in response to an amino acid challenge during Baseline [pre study compound consumption] versus post 28-day study compound consumption.	Day -3 to Day 29.
Secondary	Change in ammonia in blood for KB174 compared to Maltodextrin.	Change in ammonia in blood from Baseline to end of study for KB174 compared to maltodextrin	Day -3 to Day 43.
Secondary	Change in total urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.	Change in total urea in urine in response to an amino acid challenge during baseline [pre study compound consumption] versus post 28-day compound consumption.	Day -3 to Day 29.
Secondary	Change in 15N-urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.	Change in 15N-urea in urine in response to an amino acid challenge from baseline [pre study compound consumption ] versus post 28-day compound consumption.	Day -3 to Day 29.
Secondary	Change in 15N-urea in stool in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.	Change in 15N-urea in stool in response to an amino acid challenge from baseline [pre study compound consumption ] versus post 28-day compound consumption.	Day -3 to Day 29.
Secondary	Incidence of treatment-emergent adverse events from baseline to end of study.		Day -7 through Day 43 visit.
Secondary	Incidence of serious adverse events from base baseline to end of study.		Day -7 through Day 43.
Secondary	Change in Gastrointestinal Tolerability Questionnaire (GITQ) through the collection of daily patient questionnaires.	Evaluate the effect of KB195 on self-report questionnaires including the Gastrointestinal Tolerability Questionnaire, an assessment of the frequency and severity of GI symptoms, e.g., gas, abdominal pain, calculated on a scale from 0 (None/Not applicable) to a maximum score of 60 (Severe/Much more than usual) for all questions.	Day -7 through Day 43.
Secondary	Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires	Evaluate the effect of KB195 on self-report questionnaires including the Bristol Stool Scale, an assessment of stool consistency on a scale from 1 (separate hard lumps, like nuts, hard to pass) through 7 (watery, no solid pieces, entirely liquid).	Day -7 through Day 43.