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

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

Sponsoren

Hauptsponsor: Kaleido Biosciences

Quelle Kaleido Biosciences
Kurze Zusammenfassung

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.

Gesamtstatus Completed
Anfangsdatum February 27, 2019
Fertigstellungstermin October 1, 2019
Primäres Abschlussdatum October 1, 2019
Phase N/A
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Change in 15N in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin. Day -3 to Day 28.
Sekundäres Ergebnis
Messen Zeitfenster
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.
Change in total urea 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 15N-urea 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 15N-urea 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.
Incidence of treatment-emergent adverse events from baseline to end of study. Day -7 through Day 43 visit.
Incidence of serious adverse events from base baseline to end of study. Day -7 through Day 43.
Change in Gastrointestinal Tolerability Questionnaire (GITQ) through the collection of daily patient questionnaires. Day -7 through Day 43.
Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires Day -7 through Day 43.
Einschreibung 40
Bedingung
Intervention

Interventionsart: Other

Interventionsname: KB174

Beschreibung: KB174 is a novel mixture of oligosaccharides.

Armgruppenetikett: KB174 Arm

Interventionsart: Other

Interventionsname: Maltodextrin

Beschreibung: Maltodextrin is a commercially available easily digestible polysaccharide.

Armgruppenetikett: Maltodextrin Arm

Teilnahmeberechtigung

Kriterien:

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.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 70 Years

Gesunde Freiwillige: No

Ort
Einrichtung:
Research Centers of America | Hollywood, Florida, 33024, United States
Advanced Pharma CR, LLC | Miami, Florida, 33147, United States
Marquez Clinical Site Partners, LLC Florida Premier Research Institute | Winter Park, Florida, 32789, United States
Delta Research Partners | Monroe, Louisiana, 71201, United States
Standort Länder

United States

Überprüfungsdatum

May 2020

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: KB174 Arm

Art: Experimental

Beschreibung: KB174 is a novel mixture of oligosaccharides.

Etikette: Maltodextrin Arm

Art: Other

Beschreibung: Maltodextrin is a commercially available easily digestible polysaccharide.

Patientendaten No
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Basic Science

Maskierung: Double (Participant, Investigator)

Quelle: ClinicalTrials.gov