NCT03467282

Brief Summary

Non-alcoholic Fatty Liver Disease (NAFLD) is characterized by excessive accumulation of lipids in hepatocytes, not associated with alcohol consumption and ranges from hepatic steatosis to steatohepatitis, a form that can progress to cirrhosis or hepatocarcinoma, and is considered a liver manifestation of the metabolic syndrome (MetS). The disease occurs in 16 - 30% of the general population, but can reach up to 90% of obese individuals. Changes in lifestyle, including weight loss and physical activity are indicated with first choices for improvement of the liver condition. Recently the relationship between obesity, diabetes, MetS and NAFLD with intestinal microbiota has also been suggested in the development and progression of liver disease, since it is related to hepatic steatosis and inflammation. In this sense, this work aims to evaluate the effects of probiotic supplementation on intestinal microbiota modulation, degree of hepatic fibrosis and steatosis, inflammation and body composition.

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
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 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

November 29, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

2.7 years

First QC Date

March 9, 2018

Last Update Submit

June 17, 2020

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (2)

  • hepatic fibrosis

    change in the degree of fibrosis by hepatic elastography and scores

    24 weeks

  • cardiovascular risk

    change in scores and sistemic markers

    24 weeks

Secondary Outcomes (11)

  • diversity of gut microbiota

    24 weeks

  • inflammation by TLR4 expression

    24 weeks

  • inflammation by CK18 expression

    24 weeks

  • inflammation by serum C-reactive protein

    24 weeks

  • metabolic syndrome

    24 weeks

  • +6 more secondary outcomes

Study Arms (2)

Probiotic

EXPERIMENTAL

1g probiotic mix (twice day): Lactobacillus acidophilus 1x109 CFU + Bifidobacterium lactis 1x109 CFU + Lactobacillus rhamnosus 1x109 CFU + Lactobacillus paracasei 1x109 CFU

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

1g polydextrose/maltodextrin - twice day

Dietary Supplement: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

1g probiotic mix (twice day): Lactobacillus acidophilus 1x109 CFU + Bifidobacterium lactis 1x109 CFU + Lactobacillus rhamnosus 1x109 CFU + Lactobacillus paracasei 1x109 CFU

Probiotic
PlaceboDIETARY_SUPPLEMENT

1g polydextrose/maltodextrin - twice day

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult outpatient with diagnostic of NAFLD

You may not qualify if:

  • HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infected patients
  • significant intake of alcohol
  • cirrhosis,
  • pregnant women,
  • transplanted patients,
  • intake of supplements or foods containing probiotics,
  • immunosuppressants, antibiotics, corticosteroids, valproic acid and amiodarone,
  • other chronic inflammatory diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

Location

Related Publications (2)

  • Barcelos STA, Silva-Sperb AS, Moraes HA, Longo L, de Moura BC, Michalczuk MT, Uribe-Cruz C, Cerski CTS, da Silveira TR, Dall'Alba V, Alvares-da-Silva MR. Oral 24-week probiotics supplementation did not decrease cardiovascular risk markers in patients with biopsy proven NASH: A double-blind placebo-controlled randomized study. Ann Hepatol. 2023 Jan-Feb;28(1):100769. doi: 10.1016/j.aohep.2022.100769. Epub 2022 Oct 8.

    PMID: 36216309DERIVED

  • Silva-Sperb AS, Moraes HA, de Moura BC, Alves BC, Bruch-Bertani JP, Azevedo VZ, Dall'Alba V. Effect of probiotic supplementation in nonalcoholic steatohepatitis patients: PROBILIVER TRIAL protocol. Trials. 2019 Oct 10;20(1):580. doi: 10.1186/s13063-019-3679-7.

    PMID: 31601229DERIVED

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

  • Valesca Dall Alba

    Hospital de Clinicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 15, 2018

Study Start

November 29, 2017

Primary Completion

July 31, 2020

Study Completion

December 20, 2021

Last Updated

June 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)