NCT06074094

Brief Summary

this study aimed to evaluate the effectiveness of Probiotics supplementation (lactobacillus) on NAFLD fibrosis score.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

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

September 12, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
Last Updated

October 10, 2023

Status Verified

June 1, 2023

Enrollment Period

1.3 years

First QC Date

September 13, 2023

Last Update Submit

October 5, 2023

Conditions

NAFLD

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 week of probiotic supplementation

Secondary Outcomes (2)

  • ALT , AST

    12 week of probiotic supplementation

  • body mass index (BMI)

    12 week of probiotic supplementation

Study Arms (2)

probiotic group

EXPERIMENTAL

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.

Drug: Control Test

standard treatment group

ACTIVE COMPARATOR

Healthy lifestyle habits and standard diet was recommended for participants ,

Drug: Control Test

Interventions

Control TestDRUG

Lacteol fort 10 billion which contains culture medium and lactobacillus LS as active ingredients

Also known as: standard treatment group
probiotic groupstandard treatment group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between18 and 60
  • BMI ≥ 25 kg/m2
  • Sonographic findings of NAFLD +/- elevated liver enzymes (not more than 2 folds increase).

You may not qualify if:

  • ▪ 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11517, Egypt

Location

Related Publications (1)

  • Abd El Hamid AA, Mohamed AE, Mohamed MS, Amin GEE, Elessawy HAA, Allam MF. The effect of probiotic supplementation on non-alcoholic fatty liver disease (NAFLD) fibrosis score in patients attending a tertiary hospital clinic in Cairo, Egypt. BMC Gastroenterol. 2024 Oct 8;24(1):354. doi: 10.1186/s12876-024-03424-3.

    PMID: 39379797DERIVED

Related Links

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

October 10, 2023

Study Start

September 12, 2021

Primary Completion

December 31, 2022

Study Completion

March 1, 2023

Last Updated

October 10, 2023

Record last verified: 2023-06

Locations

EG(1)