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Probiotics in the Treatment of NAFLD

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ClinicalTrials.gov Identifier: NCT02764047
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : October 6, 2017
Sponsor:
Collaborator:
Irmandade Santa Casa de Misericórdia de Porto Alegre
Information provided by (Responsible Party):
Gabriela Zanatta Port, Federal University of Health Science of Porto Alegre

Brief Summary:
Evaluate the effect of supplementation of probiotics on liver changes (histological and enzymatic), lipid profile and gut microbiota of patients with nonalcoholic steatohepatitis (NASH).

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Fatty Liver, Nonalcoholic NAFLD Dietary Supplement: Probiotic Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Probiotics in the Treatment of Nonalcoholic Fatty Liver Disease
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsule
Dietary Supplement: Probiotic
L. acidophilus 10⁹, B. lactis 10⁹

Active Comparator: Probiotic
Probiotic capsule
Dietary Supplement: Probiotic
L. acidophilus 10⁹, B. lactis 10⁹




Primary Outcome Measures :
  1. Hepatic changes (histological) [ Time Frame: 6 months ]
    The assessment of fibrosis will be performed in all patients using noninvasive FIBROMAX test (evaluates fibrosis, inflammation and hepatic steatosis) for comparison with liver biopsy.


Secondary Outcome Measures :
  1. Hepatic changes (enzymatic) [ Time Frame: 6 months ]
    The assessment of enzymatic activity will be performed in all patients via measurements of AST , ALT .

  2. Lipid profile [ Time Frame: 6 months ]
    The assessment of lipid profile will be performed in all patients via measurements of total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides.

  3. Alterations in gut microbiota [ Time Frame: 6 months ]
    The evaluation of the intestinal microbiota will be performed in all patients by molecular analysis of stool dna test .



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years, patients with NASH confirmed by biopsy within 6 months before inclusion.

Exclusion Criteria:

  • Patients with hepatitis B virus, hepatitis C virus, alcohol consumption significantly (> 14 drinks per week for women and> 21 drinks per week for men) (Chalasani, 2012), history of decompensated liver disease (ascites, esophageal varices, encephalopathy), hepatocellular carcinoma, steroids, methotrexate, amiodarone, tamoxifen, valproate, vitamin E past 6 months, previous surgery (bariatric, gastric, intestinal resection), parenteral nutrition (TPN) the last 6 months, pregnancy or breastfeeding, history of hypothyroidism, Cushing's syndrome, diabetes type 1.

Information from the National Library of Medicine

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): NCT02764047


Contacts
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Contact: Gabriela Z Port, Master 555192799028 gabriela.port@hotmail.com
Contact: Caroline Buss, PHD 555181333580 carolinebuss@ufcspa.edu.br

Locations
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Brazil
Irmandade Santa Casa de Misericórdia Recruiting
Porto Alegre, RS, Brazil, 900200090
Contact: Cristiane V Tovo, PHD    555191893113    cris.tovo@terra.com.br   
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Irmandade Santa Casa de Misericórdia de Porto Alegre
Investigators
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Principal Investigator: Cristiane V Tovo, PHD FUHSPA

Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site

Publications of Results:
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Responsible Party: Gabriela Zanatta Port, Master, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT02764047     History of Changes
Other Study ID Numbers: 852.771
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gabriela Zanatta Port, Federal University of Health Science of Porto Alegre:
Non-alcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
NAFLD
NASH

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases