Non-Alcoholic Fatty Liver DiseaseNCT05808049
A Clinical Trial to Evaluate the Efficacy and Safety of MXP22 on Liver Health
A study testing MXP22 (Probiotic and antioxidant capsule) in people with Non-Alcoholic Fatty Liver Disease, run by Vedic Lifesciences Pvt. Ltd. at 2 sites in India.
Trial summary
A randomized, double blind, placebo controlled clinical trial to evaluate the efficacy and safety of MXP22 on liver health Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- MXP22 (Probiotic and antioxidant capsule)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesIndia
- Study dates
- 6 Oct 2022to 4 Jul 2023
- Phase
- Interventional
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult men and women aged more than equal to 30 and less than or equal to 60 years, diagnosed with NAFLD within last 2 years.
- CAP scores more than equal to 248 and less than or equal to 270 dB/m indicating steatosis grade I/ II.
- Non-alcoholics (little or no consumption of alcohol).
- Willing to participate in the study with a signed and dated written consent.
- Overweight and obese participant with BMI more than or equal to 25 kg/m2.
- Having at least 3 of the following five metabolic risk factors:
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- i Waist circumference: Men: more than or equal to102 cm (40.15 inches); Women more than or equal to 88 cm (34.65 inches).
- ii Triglycerides >150 mg/dL. iii Blood pressure more than or equal to 130 mm Hg (systolic, SBP) and/or more than or equal to 85 mm Hg (diastolic, DBP).
- iv Fasting blood glucose more than or equal to 100 mg/ dl. v Low HDL level: Men: < 40 mg/dL; Women: < 50 mg/dL.
Who cannot join
- Treatment of NAFLD for at least 3 months prior to the screening.
- History of decompensated liver disease (ascites, encephalopathy, variceal bleeding).
- Participants with liver cirrhosis, any concomitant liver disease.
- Participants with systemic inflammatory disease or autoimmune disorders.
- Participants with blood pressure Less than or equal to 160 mm Hg (systolic, SBP) and/or less than or equal to 95 mm Hg (diastolic, DBP).
- Participants with Fasting blood glucose Less than or equal to 140 mg/ dl.
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- Participants with cardiopulmonary disease.
- Heavy alcohol drinkers defined as follows:
- i For men, consuming more than 4 drinks on any day or more than 14 drinks/week ii For women, consuming more than 3 drinks on any day or more than 7 drinks/week
- Participants with liver cancer - primary hepatocellular carcinoma or liver metastasis.
- Participants with other systemic disorders of the heart, lungs, blood, and endocrine system, including thyroid dysfunction and Type I diabetes mellitus.
- Histologic evidence of NASH with fibrosis stage (METAVIR score) F1 or F4.
- Individuals with Inflammatory bowel diseases.
- Use of medications containing systemic steroids, methotrexate corticosteroids, amiodarone, tamoxifen, valproate, vitamin E, omega-3, Anti-retroviral agents; 1 month prior to screening.
- Intake of probiotics (lactic acid bacteria, etc.), prebiotics (dietary fiber, fructooligo saccharide, etc.), new biotics, fermented milk and proton pump inhibitor within one month before screening or during the study period.
- Participants who have hypersensitivity to the test drug/ placebo or components contained in the test drug/placebo or have severe allergic reactions.
- Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
- Regular use of a probiotic or prebiotic supplement within 3 months prior to screening.
- Antibiotic use within 3 weeks prior to screening.
Trial locations and contacts
2 sites in 1 country.
India2 sites
JNU institute of medical science and research
Jaipur, Rajashthan, 302017
Dr. Sudhir Maharshi Gastro clinic
Jaipur, Rajasthan, 302001
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of MXP22 on Liver Health
A randomized, double blind, placebo controlled clinical trial to evaluate the efficacy and safety of MXP22 on liver health
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- MXP22 (Probiotic and antioxidant capsule), Placebo (Microcrystalline Cellulose)
- 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.
MXP22 (Probiotic and antioxidant capsule)Other
Dose: NLT 4 Billion CFU/Capsule Route: Oral Administration Regimen: 1 capsule to be taken once daily after lunch for 120 days
Placebo (Microcrystalline Cellulose)Other
Dose: NLT 4 Billion CFU/Capsule Route: Oral Administration Regimen: 1 capsule to be taken once daily after lunch for 120 days
| Study group | Role | What they receive |
|---|---|---|
| MXP22 (Probiotic and antioxidant capsule) | Experimental | Dose : NLT 4 Billion CFU/Capsule Route: Oral Administration Regimen: 1 capsule to be taken once daily after lunch for 120 days Receives: Other: MXP22 (Probiotic and antioxidant capsule) |
| Placebo (Microcrystalline Cellulose ) | Placebo comparator | Dose : NLT 4 Billion CFU/Capsule Route: Oral Administration Regimen: 1 capsule to be taken once dailybafter lunch for 120 days Receives: Other: Placebo (Microcrystalline Cellulose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroscan
To evaluate the effect of 120 days consumption of MXP22 on hepatic steatosis as assessed by the change in Controlled Attenuation Parameter score on fibroscan from baseline to the end of the study, as compared to that in placebo
Measured: Day 120.
Secondary outcomes (5)
AST & ALT
Liver health as assessed by the significant change in the AST \& ALT levels from baseline ascompared to that in placebo.
Measured: Day 0, 60 and 120
Lipid Profile
Lipid profile as assessed by the significant change in the total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides from baseline to end point in comparison to the placebo.
Measured: Day 0, 60 and 120
Inflammatory markers
The inflammatory factors as assessed by the change in Interlukins-6 and Tumour Necrosis Factor alpha from baseline to end point in comparison to the placebo.
Measured: Day 0 and 120
serum Lipopolysaccharide level
On dietary endotoxemia as assessed by the significant change in the serum Lipopolysaccharide level after a high fat diet
Measured: Day 0 and 120
Fibroscan
To evaluate the effect of 120 days consumption of MXP22 on hepatic steatosis as assessed by the change in Controlled Attenuation Parameter score on fibroscan from baseline to the end of the study, as compared to that in placebo.
Measured: [Time Frame: Day 0, Day 60 and Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start6 Oct 2022
- Primary completion4 Jul 2023
- Study completion4 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Parallel Group, Placebo Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Sudhir Maharshi, MBBS DNB Gastro, Principal investigator, Dr. Sudhir Maharshi Gastro clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808049
- Sponsor's protocol ID
- SY/211203/MASP/NFLD
- Status last verified
- Sep 2023
- First submitted
- 14 Feb 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of MXP22 on Liver Health
- ClinicalTrials.gov ID
- NCT05808049
- Acronym / sponsor ID
- SY/211203/MASP/NFLD
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 4 Jul 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 11 Apr 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.
A randomized, double blind, placebo controlled clinical trial to evaluate the efficacy and safety of MXP22 on liver health
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, Parallel Group, Placebo Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| MXP22 (Probiotic and antioxidant capsule) | Experimental | Other: MXP22 (Probiotic and antioxidant capsule)Dose : NLT 4 Billion CFU/Capsule Route: Oral Administration Regimen: 1 capsule to be taken once daily after lunch for 120 days |
| Placebo (Microcrystalline Cellulose ) | Placebo comparator | Other: Placebo (Microcrystalline Cellulose)Dose : NLT 4 Billion CFU/Capsule Route: Oral Administration Regimen: 1 capsule to be taken once dailybafter lunch for 120 days |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adult men and women aged more than equal to 30 and less than or equal to 60 years, diagnosed with NAFLD within last 2 years.
- CAP scores more than equal to 248 and less than or equal to 270 dB/m indicating steatosis grade I/ II.
- Non-alcoholics (little or no consumption of alcohol).
- Willing to participate in the study with a signed and dated written consent.
- Overweight and obese participant with BMI more than or equal to 25 kg/m2.
Key exclusion criteria (19 listed)
- Treatment of NAFLD for at least 3 months prior to the screening.
- History of decompensated liver disease (ascites, encephalopathy, variceal bleeding).
- Participants with liver cirrhosis, any concomitant liver disease.
- Participants with systemic inflammatory disease or autoimmune disorders.
- Participants with blood pressure Less than or equal to 160 mm Hg (systolic, SBP) and/or less than or equal to 95 mm Hg (diastolic, DBP).
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 |
|---|---|---|
| MXP22 (Probiotic and antioxidant capsule)Dose: NLT 4 Billion CFU/Capsule Route: Oral Administration Regimen: 1 capsule to be taken once daily after lunch for 120 days | Other | MXP22 (Probiotic and antioxidant capsule) |
| Placebo (Microcrystalline Cellulose)Dose: NLT 4 Billion CFU/Capsule Route: Oral Administration Regimen: 1 capsule to be taken once daily after lunch for 120 days | Other | Placebo (Microcrystalline Cellulose ) |
Primary outcome
Fibroscan
Time frame: Day 120.
To evaluate the effect of 120 days consumption of MXP22 on hepatic steatosis as assessed by the change in Controlled Attenuation Parameter score on fibroscan from baseline to the end of the study, as compared to that in placebo
5 secondary outcomes
AST & ALT
Time frame: Day 0, 60 and 120
Lipid Profile
Time frame: Day 0, 60 and 120
Inflammatory markers
Time frame: Day 0 and 120
serum Lipopolysaccharide level
Time frame: Day 0 and 120
Fibroscan
Time frame: [Time Frame: Day 0, Day 60 and Day 120
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 6 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
Dr. Sudhir Maharshi, MBBS DNB Gastro principal investigator
Dr. Sudhir Maharshi Gastro clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MXP22 (Probiotic and antioxidant capsule) in people with Non-Alcoholic Fatty Liver Disease, run by Vedic Lifesciences Pvt. Ltd. at 2 sites in India.
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 9 inclusion and 19 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 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Fibroscan (time frame: Day 120.). 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 6 Sep 2023.