Effects of Probiotic on Inflammation and Microbiota in Patients With NASH
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/26/2018 |
| Start Date: | May 15, 2018 |
| End Date: | August 2019 |
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
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.
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.
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.
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.
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)
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