Effect of Probiotics in Non-alcoholic Fatty Liver Disease and Steatohepatitis (PRONE)
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|ClinicalTrials.gov Identifier: NCT04175392|
Recruitment Status : Terminated (lack of enrollment)
First Posted : November 25, 2019
Last Update Posted : May 26, 2022
|Condition or disease||Intervention/treatment||Phase|
|Fatty Liver Disease Fibrosis, Liver Cirrhosis, Liver Steatohepatitis, Nonalcoholic||Drug: Align Probiotic Supplement Capsule Drug: Placebos||Phase 1 Phase 2|
Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) are conditions without symptoms where inflammation in the liver can progress to end-stage liver disease (cirrhosis). Current standard of care for these conditions include control of metabolic syndrome which includes but is not limited to a patient's high blood pressure (hypertension), high cholesterol (hyperlipidemia), high blood sugar (hyperglycemia) and excess fat around the waist (central obesity and waist circumference) with lifestyle modifications including diet, exercise and medications. While the mechanism for inflammation on the liver in NAFLD and NASH is not completely understood, the American Association for the Study of Liver Diseases currently suspects it may be connected with the metabolism in the bowel and subsequent hepatic (liver) circulation. The bacteria of the intestines (microbiome or gut flora) may play a role in the inflammatory cascade through the bloodstream that affects the liver.
The World Health Organization (WHO) and the Food and Agricultural Organization (FAO) of the United Nations define Probiotics as a "live microorganism" which, when taken in adequate amounts confer a health benefit in the gastrointestinal tract. This study will be done to determine if probiotic use may be a viable treatment option for NAFLD and NASH and to establish a link that the intestinal microbiome or gut flora plays a role in liver inflammation which will be measured by elastography.
Patients with NAFLD and NASH seen in office consultation of the investigator will be approached to participate in the randomized like a flip of a coin, double-blind (patients and researchers will be blinded), placebo controlled study. Participant will be counseled on diet and exercise. The participants will receive information on a standardized Mediterranean diet based nutrition program as well as direction for recommended 30 minutes of aerobic exercise 3 times weekly. A baseline transient elastography, blood test such as liver enzymes Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) will be drawn, including hemoglobin A1C (diabetic marker), cholesterol in the form of Low-Density Lipoprotein (LDL/bad cholesterol) and assessment of Body Mass Index (BMI).
Participants will be randomized by pharmacy into 2 groups, a control group and a treatment group. The treatment group will be provided with a 6 month supply of Align probiotic once daily supplementation; the control group will be given a placebo for 6 months along with both groups given instructions on how to take the supplement. Subjects will receive a 1 month phone call follow up to ensure adherence to study instructions and daily oral intake of supplement, and again at 3 months. Study participation will end at 6 months after the repeat of liver enzymes, hemoglobin A1C, lipid panel, assessment of BMI and transient elastography as completed at scheduled clinical appointment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, randomized, double-blind study. Participant will be randomized to either the Treatment (Probiotic) Group or the Control (Placebo) Group.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Both Participants and Researchers will not know which treatment group assigned to.|
|Official Title:||Effect of Probiotics in Non-Alcoholic Fatty Liver Disease and Steatohepatitis Measured by Transient Elastography (PRONE Study).|
|Actual Study Start Date :||January 12, 2021|
|Actual Primary Completion Date :||March 1, 2022|
|Actual Study Completion Date :||March 1, 2022|
Active Comparator: Treatment Group: Probiotic
Probiotic 1 billion units Supplement Once Daily
Drug: Align Probiotic Supplement Capsule
Align Probiotic 1 billion units, 1 capsule once daily
Other Name: Probiotic
Placebo Comparator: Control Group: Placebo
Placebo Capsule Once Daily
Placebos capsule 1 capsule Once daily
Other Name: Placebo
- Probiotic effects on liver fibrosis [ Time Frame: 6 months ]Probiotic effects on liver fibrosis as measured by transient elastography, as a change from baseline to 6 months, measured in kilopascals (KPa). Positive numbers indicate an increase in fibrosis; negative numbers indicate decrease in fibrosis
- Probiotic effects on Liver enzymes, AST [ Time Frame: 6 months ]Probiotic effects on Liver enzymes, AST as a change from baseline to 6 months, measured in units per liter. Positive numbers indicate an increase in AST; negative numbers indicate decrease in AST
- Probiotic effects on Liver enzymes, ALT [ Time Frame: 6 months ]Probiotic effects on Liver enzymes, ALT as a change from baseline to 6 months, measured in units per liter. Positive numbers indicate an increase in ALT; negative numbers indicate decrease in ALT
- Probiotic effects on Diabetic Markers [ Time Frame: 6 months ]Probiotic effects on Diabetic Markers as measured by hemoglobin A1C blood test as a change from baseline to 6 months, measured in percent. Positive numbers indicate an increase in hemoglobin A1c; negative numbers indicate decrease in hemoglobin A1c
- Probiotic effects on BMI [ Time Frame: 6 months ]Probiotic effects on Body Mass Index (BMI) wherein weight and height will be combined to report BMI in kg/m^2 as a change from baseline to 6 months. Positive numbers indicate an increase in BMI; negative numbers indicate decrease in BMI.
- Probiotic effects on LDL [ Time Frame: 6 months ]Probiotic effects on Low-density Lipoprotein (LDL) as a change from baseline to 6 months, measured in milligrams per deciliter. Positive numbers indicate an increase in LDL; negative numbers indicate decrease in LDL
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): NCT04175392
|United States, Michigan|
|Farmington Hills, Michigan, United States, 48336|
|Principal Investigator:||Mariquit Sendelbach, DO||William Beaumont Hospitals|