Effects of Probiotic on Inflammation and Microbiota in Patients With NASH (NASHPro)
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|ClinicalTrials.gov Identifier: NCT03511365|
Recruitment Status : Enrolling by invitation
First Posted : April 27, 2018
Last Update Posted : July 24, 2018
|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|
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.
|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|
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.
- Change in Il-17 levels with probiotic administration [ Time Frame: 8 weeks ]Percent decrease in Il levels will be recorded.
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
|United States, New York|
|Manhasset, New York, United States, 11030|