Effect of Probiotics in Non-alcoholic Fatty Liver Disease and Steatohepatitis

NCT04175392 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 2019-129
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effect of probiotics, a beneficial intestinal bacteria supplement, if it will cause improvement of the non-alcoholic fatty liver disease (NAFLD) and or non-alcoholic steatohepatitis (NASH- an inflammation with concurrent fatty accumulation of the liver) as measured by transient elastography - an ultrasound of the liver that assess the elastic properties (density) and stiffness of the liver tissue. This study will enroll patients 18 years and older with diagnosis of NAFLD and or NASH.

Conditions

Fatty Liver Disease; Fibrosis, Liver; Cirrhosis, Liver; Steatohepatitis, Nonalcoholic

Keywords

Fatty Liver; Fibrosis; Cirrhosis; Probiotic; Steatohepatitis; Elastography

Outcome Measures

Primary Outcomes (1)

• Probiotic Effects on Liver Fibrosis

  Probiotic effects on liver fibrosis as measured by transient elastography, as a change from baseline to 6 months, measured on a scale from 1-4. 1= a clinical grade of F0-F1 and represents 2-7 kilopascals in elastography testing. 4= a clinical grade of F4 and represents 14 kilopascals or higher in elastography testing. A higher score on the scale represents worsening liver scarring. Positive numbers indicate an increase in fibrosis; negative numbers indicate decrease in fibrosis.

  6 months

Secondary Outcomes (5)

• Probiotic Effects on Liver Enzymes, AST

  6 months

• Probiotic Effects on Liver Enzymes, ALT

  6 months

• Probiotic Effects on Diabetic Markers

  6 months

• Probiotic Effects on BMI

  6 months

• Probiotic Effects on LDL

  6 months

Study Arms (2)

Treatment Group: Probiotic

ACTIVE COMPARATOR

Probiotic 1 billion units Supplement Once Daily

Drug: Align Probiotic Supplement Capsule

Control Group: Placebo

PLACEBO COMPARATOR

Placebo Capsule Once Daily

Drug: Placebos

Interventions

Align Probiotic Supplement Capsule DRUG

Align Probiotic 1 billion units, 1 capsule once daily

Also known as: Probiotic

Treatment Group: Probiotic

Placebos DRUG

Placebos capsule 1 capsule Once daily

Also known as: Placebo

Control Group: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of NAFLD and/or NASH
• Subject aged 18 and older
• Non-pregnant - Self-reported
• Subject with decision making capacity to understand and consent to study procedures
• Ability to follow study related activities regarding medications, diet and exercise

You may not qualify if:

• Without diagnosis of NAFLD or NASH
• History of liver disease from other causes, including but not limited to hepatitis, autoimmune, alcohol use, fatty liver of pregnancy, Wilson's disease, primary or secondary hemochromatosis
• Patients aged less than 18 years
• Self-reported pregnant patients
• Inability to understand, follow and consent to study procedures
• Hepatic decompensation defined as gastrointestinal bleeding, ascites, hepatic encephalopathy
• Inability to engage in exercise
• Currently immunocompromised or taking immunosuppressive drugs
• Milk protein allergy
• Recent or active chemotherapy for malignancy
• Gastrointestinal malignancy
• Gastrointestinal disease such as Ulcerative Colitis, Crohn's Disease as these alter the microbiome
• Recent antibiotic therapy (within 6 months)
• Known allergy to probiotics
• History of major gastrointestinal surgery such as resection of the colon

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Hospital

Farmington Hills, Michigan, 48336, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Fatty Liver; Fibrosis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Kirsten Gage, CRM
• Organization: Beaumont Hospitals

kirsten.gage@beaumont.org

947-521-8519

Study Officials

• Mariquit Sendelbach, DO

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both Participants and Researchers will not know which treatment group assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized, double-blind study. Participant will be randomized to either the Treatment (Probiotic) Group or the Control (Placebo) Group.

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: January 12, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: September 27, 2022
• Results First Posted: September 27, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)