- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05808049
A 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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr. Shalini Srivasatava, MBBS MD
- Phone Number: 022242172300
- Email: shalini.s@vediclifesciences.com
Study Contact Backup
- Name: Henali Bhoir, B Pharm
- Phone Number: 7738387606
- Email: henali.b@vediclifesciences.com
Study Locations
-
-
Rajashthan
-
Jaipur, Rajashthan, India, 302017
- JNU institute of medical science and research
-
-
Rajasthan
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Jaipur, Rajasthan, India, 302001
- Dr. Sudhir Maharshi Gastro clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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:
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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Dose: NLT 4 Billion CFU/Capsule Route: Oral Administration Regimen: 1 capsule to be taken once daily after lunch for 120 days
|
Placebo Comparator: Placebo (Microcrystalline Cellulose )
Dose : NLT 4 Billion CFU/Capsule Route: Oral Administration Regimen: 1 capsule to be taken once dailybafter lunch for 120 days
|
Dose: NLT 4 Billion CFU/Capsule Route: Oral Administration Regimen: 1 capsule to be taken once daily after lunch for 120 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 120.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AST & ALT
Time Frame: Day 0, 60 and 120
|
Liver health as assessed by the significant change in the AST & ALT levels from baseline ascompared to that in placebo.
|
Day 0, 60 and 120
|
Lipid Profile
Time Frame: Day 0, 60 and 120
|
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.
|
Day 0, 60 and 120
|
Inflammatory markers
Time Frame: Day 0 and 120
|
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.
|
Day 0 and 120
|
serum Lipopolysaccharide level
Time Frame: Day 0 and 120
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On dietary endotoxemia as assessed by the significant change in the serum Lipopolysaccharide level after a high fat diet
|
Day 0 and 120
|
Fibroscan
Time Frame: [Time Frame: Day 0, Day 60 and 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.
|
[Time Frame: Day 0, Day 60 and Day 120
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr. Sudhir Maharshi, MBBS DNB Gastro, Dr. Sudhir Maharshi Gastro clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SY/211203/MASP/NFLD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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