Effects of Probiotic on Inflammation and Microbiota in Pa... | NCT03511365

Studies
Effects of Probiotic on Inflammation and Microbiota in Patients With NASH

NCT03511365

Sponsor

Northwell Health

Status

Terminated

Last Update Posted

Jan 7, 2020Actual

Enrollment

6Actual

Phase

Phase 1Phase 2

Conditions

Non-Alcoholic Fatty Liver Disease
Probiotics MeSH Descriptor Data 2018
Interleukin-17 MeSH Descriptor Data 2018

Interventions

Probiotic Formulation VSL#3

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

IRB haulted the study there was no evidence that the probiotic would benefit the patient

Expanded Access Info

Start Date

May 15, 2018Actual

Primary Completion Date

Dec 14, 2018Actual

Completion Date

Oct 11, 2019Actual

First Submitted Date

Apr 6, 2018

First Submission Date that Met QC Criteria

Apr 18, 2018

First Posted Date

Apr 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2020

Last Update Posted Date

Jan 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Individuals with clinically identified non-alcoholic fatty liver disease will undergo baseline evaluation of IL-17 and other inflammatory markers as well as microbiome determination. The probiotic formulation VSL#3 450 Billion CFU twice daily will be administered for 8 weeks and the determination of Il-17 and microbiome will be repeated. Each subject will serve as his or her own control.

Detailed Description

This study is designed as a prospective trial of the effects of probiotic on inflammatory and stool profiles in patients with NAFLD. These patients are actively followed by the Division of Hepatology. They will have confirmed normal liver function tests and absence of hepatitis C virus in order to be eligible for this study. Eligible subjects will be identified within the outpatient setting of the Division of Hepatology of the Northwell Health System.

Division of Hepatology 400 Community Drive Manhasset, NY 11030 516-562-4281

Candidate subjects will be identified by investigators as a part of their typical work flow. Subjects will be evaluated according to inclusion and exclusion criteria presented. Eligible patients will be provided with a packet containing study information and informed consent documents. Should a patient remain interested in study participation, informed consent will be obtained. Financial compensation will not be provided to subjects.

Forty patients with NAFLD will be enrolled.

Following enrollment and informed consent, subjects will undergo the following assessments:

Medical History Questionnaire
Current Medication List

Blood and stool samples will be obtained prior to study initiation and again after 8 weeks of exposure.

Protocol for biological sample collection:

Whole Blood Collection - Venipuncture will be performed under standard conditions. Three heparinized tubes will be obtained which each tube containing approximately 10 cc of whole blood Samples will be de-identified. Peripheral Blood Cells will be isolated from whole blood samples according to standard protocols.

Serum cytokine levels, including IL-10 and IL-17, will be assessed.

Stool Collection - Patients will be provided with stool collection kits. Samples will be de-identified. Stool samples will be preserved in a -20 degree freezer in the Division of Infectious Diseases.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic administration	Experimental	After baseline collection of serum and fecal microbiota, each subject will be administered the probiotic formulation VSL#3 450 Billion CFU Twice daily for 8 weeks. Serum and fecal microbiota will again be collected at the end of the intervention and compared with baseline with each subject serving as his or her own control.	Biological: Probiotic Formulation VSL#3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotic Formulation VSL#3	Biological	Probiotic VSL#3 administration.	Probiotic administration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Il-17 levels with probiotic administration	Percent decrease in Il levels will be recorded.	8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older
Capable of giving informed consent
Diagnosed with NAFLD as defined by the American Association for the Study of Liver Diseases (AASLD) who are treated or seen solely at the outpatient clinic at the Department of Hepatology at 400 Community Drive in Manhasset NY

Exclusion Criteria:

Cirrhosis
Absence of secondary causes of hepatic fat accumulation including:
Excessive alcohol consumption
Hepatitis C
Wilson's Disease
Lipodystrophy
Starvation
Parenteral Nutrition
Abetalipoproteinemia
Specific Medications: Amiodarone, Methotrexate, Tamoxifen, Corticosteroids, Valproate, Anti-retroviral agents)
Reye's Syndrome
HELLP Syndrome
Inborn errors of metabolism (LCAT deficiency, cholesterol ester storage disease, Wolman disease)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwell Health		Manhasset	New York	11030	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26884164	Background	Li J, Sung CY, Lee N, Ni Y, Pihlajamaki J, Panagiotou G, El-Nezami H. Probiotics modulated gut microbiota suppresses hepatocellular carcinoma growth in mice. Proc Natl Acad Sci U S A. 2016 Mar 1;113(9):E1306-15. doi: 10.1073/pnas.1518189113. Epub 2016 Feb 16.

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases
D010335	Pathologic Processes

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D007249	Inflammation