NCT03855956

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

February 27, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

February 25, 2019

Last Update Submit

May 12, 2020

Conditions

Early Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Change in 15N in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.

    Day -3 to Day 29.

  • Change in total nitrogen in blood in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.

    Day -3 to Day 27.

  • Change in total nitrogen in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.

    Day -3 to Day 29.

  • . Change in total nitrogen in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.

    Day -3 to Day 29.

  • Change in ammonia in blood for KB174 compared to Maltodextrin.

    Day -3 to Day 43.

  • +7 more secondary outcomes

Study Arms (2)

KB174 Arm

EXPERIMENTAL

KB174 is a novel mixture of oligosaccharides.

Other: KB174

Maltodextrin Arm

OTHER

Maltodextrin is a commercially available easily digestible polysaccharide.

Other: Maltodextrin

Interventions

KB174OTHER

KB174 is a novel mixture of oligosaccharides.

KB174 Arm
MaltodextrinOTHER

Maltodextrin is a commercially available easily digestible polysaccharide.

Maltodextrin Arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Centers of America

Hollywood, Florida, 33024, United States

Location

Advanced Pharma CR, LLC

Miami, Florida, 33147, United States

Location

Marquez Clinical Site Partners, LLC Florida Premier Research Institute

Winter Park, Florida, 32789, United States

Location

Delta Research Partners

Monroe, Louisiana, 71201, United States

Location

MeSH Terms

Conditions

Fibrosis

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

February 27, 2019

Study Start

February 27, 2019

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

May 14, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(4)