NAFLDPhase 4NCT06074094
Probiotic Supplementation IN NAFLD Patients
A Phase 4 study of NAFLD, run by Ain Shams University at 1 site in Egypt.
Trial summary
this study aimed to evaluate the effectiveness of Probiotics supplementation (lactobacillus) on NAFLD fibrosis score. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Sep 2021to 1 Mar 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between18 and 60
- BMI ≥ 25 kg/m2
- Sonographic findings of NAFLD +/- elevated liver enzymes (not more than 2 folds increase).
Who cannot join
- ▪ 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Probiotic Supplementation on Non-alcoholic Fatty Liver Disease in Patients Attending Family Medicine Clinic in Ain Shams University Hospitals
this study aimed to evaluate the effectiveness of Probiotics supplementation (lactobacillus) on NAFLD fibrosis score.
Read the 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.
- Conditions
- NAFLD
- Being tested
- Control Test
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control TestDrug
Also called standard treatment group
Lacteol fort 10 billion which contains culture medium and lactobacillus LS as active ingredients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Control Test |
| standard treatment group | Active comparator | Healthy lifestyle habits and standard diet was recommended for participants , Receives: Drug: Control Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 week of probiotic supplementation
Secondary outcomes (2)
ALT , AST
effect of probiotic on ALT and AST
Measured: 12 week of probiotic supplementation
body mass index (BMI)
effect of probiotic on body mass index (BMI)
Measured: 12 week of probiotic supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start12 Sep 2021
- Primary completion31 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074094
- Sponsor's protocol ID
- probiotic and NAFLD
- Status last verified
- Jun 2023
- First submitted
- 13 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: when appropriate.
Publications
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.
PubMed 39379797
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Supplementation on Non-alcoholic Fatty Liver Disease in Patients Attending Family Medicine Clinic in Ain Shams University Hospitals
- ClinicalTrials.gov ID
- NCT06074094
- Acronym / sponsor ID
- probiotic and NAFLD
- Conditions
- NAFLD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 12 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic group | Experimental | Drug: Control TestHealthy 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. |
| standard treatment group | Active comparator | Drug: Control TestHealthy lifestyle habits and standard diet was recommended for participants , |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between18 and 60
- BMI ≥ 25 kg/m2
- Sonographic findings of NAFLD +/- elevated liver enzymes (not more than 2 folds increase).
Key exclusion criteria (8 listed)
- ▪ Any evidence of chronic liver diseases including viral hepatitis (B and C), auto immune hepatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control TestAlso: standard treatment groupLacteol fort 10 billion which contains culture medium and lactobacillus LS as active ingredients | Drug | probiotic group, standard treatment group |
Primary outcome
non alcoholic fatty liver disease (NAFLD) fibrosis score
Time frame: 12 week of probiotic supplementation
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.
2 secondary outcomes
ALT , AST
Time frame: 12 week of probiotic supplementation
body mass index (BMI)
Time frame: 12 week of probiotic supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 39379797Abd 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. when appropriate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of NAFLD, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
non alcoholic fatty liver disease (NAFLD) fibrosis score (time frame: 12 week of probiotic supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06074094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.