Fatty Liver DiseasePhase 2MAFLDNCT05966025
Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD)
A Phase 2 study testing Itopride and conventional therapy in people with Fatty Liver Disease and Fatty Liver, run by October 6 University at 1 site in Egypt.
Trial summary
Objective of this study is to determine the clinical benefits of itopride in improvement of MAFLD Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fatty Liver Disease, Fatty Liver
- What is being tested?
- Itopride and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Dec 2023to Dec 2025
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients presented to hepatology clinic . -Patients are diagnosed by ultrasonography and laboratory tests for liver and lipids. - -
- Patients with comorbidites like hypertension,diabetes,dyslipidemia
Who cannot join
- Exclusion criteria included the presence of liver disease due to any of the following: viral hepatitis (HBV, HCV)
- acute systemic disease
- cystic fibrosis, coeliac disease
- suspicion of muscular dystrophy, alpha-1-antitrypsin deficiency
- metabolic inherited diseases
- autoimmune hepatitis, drug toxicity and drugs known to induce steatosis (e.g. valproate, amiodarone orprednisone).
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- Patients were also excluded if body weight and carbohydrate metabolism were altered by the use of parenteral nutrition
- protein malnutrition
- previous gastrointestinal surgery
- structural abnormalitiesof the gastrointestinal tract or neurological impairment.
- the use of nonsteroidal anti-inflammatory drugs,antibiotics,sglt2,dpp4,statins,glp1
- probiotics or anti-secretory drugs capable of causing achlorhydria within 2 months preceding enrolmentwere also considered exclusion criteria.
- Patient with age below 18 or above 60
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Maha Youssif Fekry
Giza, 12573
maha y fekry, beclore, 01111349592 ext. october6, maha.youssif.ph@o6u.edu.eg
Engy ah wahsh, lec o6u, 01003095692 ext. october6, engywahsh@o6u.edu.eg
About this study
Official title: Evaluation of the Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease
Objective of this study is to determine the clinical benefits of itopride in improvement of MAFLD
Read the detailed description
the study will evaluate the possible benefits of itopride when added to pateints with metabolic associated fatty liver disease
- Conditions
- Fatty Liver Disease, Fatty Liver
- Being tested
- Itopride, conventional therapy
- Keywords
- Itopride in Mafld
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItoprideDrug
itopride will be taken by pateints one time per day by dose 100 mg
Also called Anti hypertensive druds, anti hyperlipidemic drugs
will taken by patient in control group
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | • control group Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy Receives: Drug: conventional therapy |
| interventions: drug itopride | Experimental | • itopride group Weight reduction and life style modification and receive (itopride) 100 mg once dialy for 24 weeks plus their conventional therapy Receives: Drug: Itopride; Drug: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of MAFLD
Highly sensitive CRP in mg\L by ELIZA, Fibro scan in MHzby fibroscan apparatus, ALT,AST in unit\liter by blood test
Measured: "1 Year "
Secondary outcomes (1)
Incidence of mafld
Decrease LDL in mg\dl, Triglyceride and total cholesterolin mg\dl ,HOMA-IR in mg\dl, IL6,TNF alpha in mg\l by eliza
Measured: " 1 Year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start28 Dec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Collaborators
- Beni-Suef University
- Responsible party
- Principal investigator, Maha youssif, October 6 University
- Investigators
- Hoda m rabea, A Professor, Principal investigator, Beni-suaf universityYasmine m madney, Lecturer, Principal investigator, Beni-suaf university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966025
- Sponsor's protocol ID
- REC-H-PhBSU-23006
- Acronym
- MAFLD
- Status last verified
- Oct 2023
- First submitted
- 14 Jul 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05966025
- Acronym / sponsor ID
- MAFLD / REC-H-PhBSU-23006
- Conditions
- Fatty Liver Disease, Fatty Liver
- Keywords
- Itopride in Mafld
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Collaborators
- Beni-Suef University
- Study start
- 28 Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Jul 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.
Objective of this study is to determine the clinical benefits of itopride in improvement of MAFLD
Detailed description
the study will evaluate the possible benefits of itopride when added to pateints with metabolic associated fatty liver disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Drug: conventional therapy• control group Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy |
| interventions: drug itopride | Experimental | Drug: Itopride, Drug: conventional therapy• itopride group Weight reduction and life style modification and receive (itopride) 100 mg once dialy for 24 weeks plus their conventional therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients presented to hepatology clinic . -Patients are diagnosed by ultrasonography and laboratory tests for liver and lipids. - -
- Patients with comorbidites like hypertension,diabetes,dyslipidemia
Key exclusion criteria (13 listed)
- Exclusion criteria included the presence of liver disease due to any of the following: viral hepatitis (HBV, HCV)
- acute systemic disease
- cystic fibrosis, coeliac disease
- suspicion of muscular dystrophy, alpha-1-antitrypsin deficiency
- metabolic inherited diseases
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 |
|---|---|---|
| Itoprideitopride will be taken by pateints one time per day by dose 100 mg | Drug | interventions: drug itopride |
| conventional therapyAlso: Anti hypertensive druds, anti hyperlipidemic drugswill taken by patient in control group | Drug | control group, interventions: drug itopride |
Primary outcome
incidence of MAFLD
Time frame: "1 Year "
Highly sensitive CRP in mg\L by ELIZA, Fibro scan in MHzby fibroscan apparatus, ALT,AST in unit\liter by blood test
1 secondary outcome
Incidence of mafld
Time frame: " 1 Year"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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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.
Hoda m rabea, A Professor principal investigator
Beni-suaf university
Yasmine m madney, Lecturer principal investigator
Beni-suaf university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Itopride and conventional therapy in people with Fatty Liver Disease and Fatty Liver, run by October 6 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 2 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 31 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maha y fekry, beclore (01111349592 ext. october 6, maha.youssif.ph@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of MAFLD (time frame: "1 Year "). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2023.