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Effects of Probiotic on Inflammation and Microbiota in Patients With NASH (NASHPro)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03511365
Recruitment Status : Enrolling by invitation
First Posted : April 27, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Bruce Hirsch, Northwell Health

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.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Probiotics MeSH Descriptor Data 2018 Interleukin-17 MeSH Descriptor Data 2018 Biological: Probiotic Formulation VSL#3 Phase 1 Phase 2

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:

  1. Medical History Questionnaire
  2. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single group interventional pilot study with each subject serving as his or her own control
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Alterations in Serum Inflammatory Markers and Fecal Microbiota Following Administration of the Probiotic Formulation VSL#3 in Patients With Nonalcoholic Fatty Liver Disease
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019


Arm Intervention/treatment
Experimental: Probiotic administration
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
Probiotic VSL#3 administration.




Primary Outcome Measures :
  1. Change in Il-17 levels with probiotic administration [ Time Frame: 8 weeks ]
    Percent decrease in Il levels will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511365


Locations
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United States, New York
Northwell Health
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health

Publications:
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Responsible Party: Bruce Hirsch, Assistant Professor of Medicine, Northwell Health
ClinicalTrials.gov Identifier: NCT03511365     History of Changes
Other Study ID Numbers: 17-0514
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bruce Hirsch, Northwell Health:
Probiotic
Microbiome
Inflammation
Non-Alcoholic Fatty Liver Disease

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases