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Probiotic Supplementation IN NAFLD Patients

Primary Purpose

NAFLD

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Control Test
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age between18 and 60 BMI ≥ 25 kg/m2 Sonographic findings of NAFLD +/- elevated liver enzymes (not more than 2 folds increase). Exclusion Criteria: ▪ Any evidence of chronic liver diseases including viral hepatitis (B and C), auto immune hepatitis. History of alcohol drinking. Chronic medication use (drugs that cause elevated liver enzymes, recent antibiotic use or paracetamol use in the last month) Persistent elevation of liver enzymes for 3 months. History of DM. History of statin therapy for cardiovascular disease (CVD). History of recent operation. History of gastroenteritis or diarrhea in the last 2 week.

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

probiotic group

standard treatment group

Arm Description

Healthy lifestyle habits and standard diet was recommended for participants ,Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus LS as active ingredients was administered in the form of oral sachets once daily for 12 weeks.

Healthy lifestyle habits and standard diet was recommended for participants ,

Outcomes

Primary Outcome Measures

non alcoholic fatty liver disease (NAFLD) fibrosis score
NAFLD fibrosis score constructed from routine clinical and laboratory variables can accurately predict the presence or absence of advanced fibrosis in NAFLD This scoring system had an area under the ROC curve of 0.88 (95% CI 0.85-0.92). 2 cutoff points were selected to identify the presence (> 0.676) and absence (< -1.455) of significant fibrosis.

Secondary Outcome Measures

ALT , AST
effect of probiotic on ALT and AST
body mass index (BMI)
effect of probiotic on body mass index (BMI)

Full Information

First Posted
September 13, 2023
Last Updated
October 5, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT06074094
Brief Title
Probiotic Supplementation IN NAFLD Patients
Official Title
Effect of Probiotic Supplementation on Non-alcoholic Fatty Liver Disease in Patients Attending Family Medicine Clinic in Ain Shams University Hospitals
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 12, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
this study aimed to evaluate the effectiveness of Probiotics supplementation (lactobacillus) on NAFLD fibrosis score.
Detailed Description
Non-alcoholic fatty liver disease (NAFLD) is a disease characterized by accumulation of fat (> 5% of the liver tissue), in the absence of alcohol abuse or other chronic liver diseases. NAFLD can cause liver inflammation and progress to non-alcoholic steatohepatitis (NASH), fibrosis, cirrhosis or hepatocellular carcinoma (HCC). The global prevalence of NAFLD in adults is estimated to be approximately 25%.The prevalence of NAFLD increases with increasing body mass index. in 2012 Chalasani et al, reported that 67% of overweight and 94% of obese individuals have NAFLD. There is a consensus regarding increasing worldwide prevalence of NAFLD and its impact on health, especially the progression to liver cirrhosis and hepatocellular carcinoma. Longitudinal studies of NAFLD have reported an increase in all-cause mortality, cardiovascular mortality, and liver-related mortality , NAFLD carries a large economic burden and therefore poor health-related quality of life. Lifestyle changes (diet and exercise) are the major and first suggestions of the guidelines ,as regard pharmaceutical interventions, agents with potential benefit in NASH include thiazolidinediones (TZDs), statins although they are well recognized in the treatment of dyslipidemia, their use as a specific treatment for NAFLD is not well evidenced. There is some data suggest that disruptions in the gut microbiome may play a role in the pathogenesis of NAFLD and progressions to NASH. A probiotic is a live microbial culture or cultured dairy product, which plays an important role in health. Probiotics for the treatment of NAFLD are seemingly a promising treatment option. Relatively easy availability, low cost, and absence of serious side effects make probiotics a lucrative choice. liver biopsy remains the gold standard for NAFLD diagnosis but it is impractical as a diagnostic tool because it is invasive and expensive. NAFLD fibrosis score constructed from routine clinical and laboratory variables can accurately predict the presence or absence of advanced fibrosis in NAFLD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
probiotic group
Arm Type
Experimental
Arm Description
Healthy lifestyle habits and standard diet was recommended for participants ,Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus LS as active ingredients was administered in the form of oral sachets once daily for 12 weeks.
Arm Title
standard treatment group
Arm Type
Active Comparator
Arm Description
Healthy lifestyle habits and standard diet was recommended for participants ,
Intervention Type
Drug
Intervention Name(s)
Control Test
Other Intervention Name(s)
standard treatment group
Intervention Description
Lacteol fort 10 billion which contains culture medium and lactobacillus LS as active ingredients
Primary Outcome Measure Information:
Title
non alcoholic fatty liver disease (NAFLD) fibrosis score
Description
NAFLD fibrosis score constructed from routine clinical and laboratory variables can accurately predict the presence or absence of advanced fibrosis in NAFLD This scoring system had an area under the ROC curve of 0.88 (95% CI 0.85-0.92). 2 cutoff points were selected to identify the presence (> 0.676) and absence (< -1.455) of significant fibrosis.
Time Frame
12 week of probiotic supplementation
Secondary Outcome Measure Information:
Title
ALT , AST
Description
effect of probiotic on ALT and AST
Time Frame
12 week of probiotic supplementation
Title
body mass index (BMI)
Description
effect of probiotic on body mass index (BMI)
Time Frame
12 week of probiotic supplementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between18 and 60 BMI ≥ 25 kg/m2 Sonographic findings of NAFLD +/- elevated liver enzymes (not more than 2 folds increase). Exclusion Criteria: ▪ Any evidence of chronic liver diseases including viral hepatitis (B and C), auto immune hepatitis. History of alcohol drinking. Chronic medication use (drugs that cause elevated liver enzymes, recent antibiotic use or paracetamol use in the last month) Persistent elevation of liver enzymes for 3 months. History of DM. History of statin therapy for cardiovascular disease (CVD). History of recent operation. History of gastroenteritis or diarrhea in the last 2 week.
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
11517
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
when appropriate.
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/28521870/
Description
Related Info
URL
https://www.nice.org.uk/guidance/ng49
Description
Related Info

Learn more about this trial

Probiotic Supplementation IN NAFLD Patients

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