NCT02764047

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

2.9 years

First QC Date

April 27, 2016

Last Update Submit

October 5, 2017

Conditions

Non-alcoholic Fatty Liver DiseaseNonalcoholic SteatohepatitisFatty Liver, NonalcoholicNAFLD

Keywords

Non-alcoholic Fatty Liver DiseaseNonalcoholic SteatohepatitisNAFLDNASH

Outcome Measures

Primary Outcomes (1)

  • Hepatic changes (histological)

    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.

    6 months

Secondary Outcomes (3)

  • Hepatic changes (enzymatic)

    6 months

  • Lipid profile

    6 months

  • Alterations in gut microbiota

    6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo capsule

Dietary Supplement: Probiotic

Probiotic

ACTIVE COMPARATOR

Probiotic capsule

Dietary Supplement: Probiotic

Interventions

ProbioticDIETARY_SUPPLEMENT

L. acidophilus 10⁹, B. lactis 10⁹

PlaceboProbiotic

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irmandade Santa Casa de Misericórdia

Porto Alegre, Rio Grande do Sul, 900200090, Brazil

RECRUITING

Related Publications (6)

  • Ma YY, Li L, Yu CH, Shen Z, Chen LH, Li YM. Effects of probiotics on nonalcoholic fatty liver disease: a meta-analysis. World J Gastroenterol. 2013 Oct 28;19(40):6911-8. doi: 10.3748/wjg.v19.i40.6911.

    PMID: 24187469RESULT

  • Loguercio C, Federico A, Tuccillo C, Terracciano F, D'Auria MV, De Simone C, Del Vecchio Blanco C. Beneficial effects of a probiotic VSL#3 on parameters of liver dysfunction in chronic liver diseases. J Clin Gastroenterol. 2005 Jul;39(6):540-3. doi: 10.1097/01.mcg.0000165671.25272.0f.

    PMID: 15942443RESULT

  • Wong VW, Won GL, Chim AM, Chu WC, Yeung DK, Li KC, Chan HL. Treatment of nonalcoholic steatohepatitis with probiotics. A proof-of-concept study. Ann Hepatol. 2013 Mar-Apr;12(2):256-62.

    PMID: 23396737RESULT

  • Shavakhi A, Minakari M, Firouzian H, Assali R, Hekmatdoost A, Ferns G. Effect of a Probiotic and Metformin on Liver Aminotransferases in Non-alcoholic Steatohepatitis: A Double Blind Randomized Clinical Trial. Int J Prev Med. 2013 May;4(5):531-7.

    PMID: 23930163RESULT

  • Aller R, De Luis DA, Izaola O, Conde R, Gonzalez Sagrado M, Primo D, De La Fuente B, Gonzalez J. Effect of a probiotic on liver aminotransferases in nonalcoholic fatty liver disease patients: a double blind randomized clinical trial. Eur Rev Med Pharmacol Sci. 2011 Sep;15(9):1090-5.

    PMID: 22013734RESULT

  • Escouto GS, Port GZ, Tovo CV, Fernandes SA, Peres A, Dorneles GP, Houde VP, Varin TV, Pilon G, Marette A, Buss C. Probiotic Supplementation, Hepatic Fibrosis, and the Microbiota Profile in Patients with Nonalcoholic Steatohepatitis: A Randomized Controlled Trial. J Nutr. 2023 Jul;153(7):1984-1993. doi: 10.1016/j.tjnut.2023.05.019. Epub 2023 May 22.

    PMID: 37225124DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Cristiane V Tovo, PHD

    FUHSPA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriela Z Port, Master

CONTACT

555192799028gabriela.port@hotmail.com

Caroline Buss, PHD

CONTACT

555181333580carolinebuss@ufcspa.edu.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master

Study Record Dates

First Submitted

April 27, 2016

First Posted

May 6, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

October 6, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)