- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03511365
Effects of Probiotic on Inflammation and Microbiota in Patients With NASH (NASHPro)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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New York
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Manhasset, New York, United States, 11030
- Northwell Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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Probiotic VSL#3 administration.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Il-17 levels with probiotic administration
Time Frame: 8 weeks
|
Percent decrease in Il levels will be recorded.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-0514
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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