Clinical trial NCT03855956: Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Cirrhosis
Lead sponsor: Kaleido Biosciences
Sponsor class: INDUSTRY
First posted: 2019-02-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in 15N in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
timeFrame: Day -3 to Day 28.
Secondary outcomes:
measure: Change in 15N in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
timeFrame: Day -3 to Day 29.
measure: Change in total nitrogen in blood in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
timeFrame: Day -3 to Day 27.
measure: Change in total nitrogen in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
timeFrame: Day -3 to Day 29.
measure: . Change in total nitrogen in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
timeFrame: Day -3 to Day 29.
measure: Change in ammonia in blood for KB174 compared to Maltodextrin.
timeFrame: Day -3 to Day 43.
measure: Change in total urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.
timeFrame: Day -3 to Day 29.
measure: Change in 15N-urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.
timeFrame: Day -3 to Day 29.
measure: Change in 15N-urea in stool in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.
timeFrame: Day -3 to Day 29.
measure: Incidence of treatment-emergent adverse events from baseline to end of study.
timeFrame: Day -7 through Day 43 visit.
measure: Incidence of serious adverse events from base baseline to end of study.
timeFrame: Day -7 through Day 43.
measure: Change in Gastrointestinal Tolerability Questionnaire (GITQ) through the collection of daily patient questionnaires.
timeFrame: Day -7 through Day 43.
measure: Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires
timeFrame: Day -7 through Day 43.
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Winter Park
country: United States
facility: Marquez Clinical Site Partners, LLC Florida Premier Research Institute
state: Florida
city: Monroe
country: United States
facility: Delta Research Partners
state: Louisiana
Study officials:
References: