Clinical trial NCT05808049: A Clinical Trial to Evaluate the Efficacy and Safety of MXP22 on Liver Health
Official title: A Randomized, Double Blind, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of MXP22 on Liver Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Parallel Group, Placebo Controlled Trial
Primary purpose: OTHER

Brief summary: A randomized, double blind, placebo controlled clinical trial to evaluate the efficacy and safety of MXP22 on liver health


Eligibility criteria: Inclusion Criteria:

1. 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.
2. CAP scores more than equal to 248 and less than or equal to 270 dB/m indicating steatosis grade I/ II.
3. Non-alcoholics (little or no consumption of alcohol).
4. Willing to participate in the study with a signed and dated written consent.
5. Overweight and obese participant with BMI more than or equal to 25 kg/m2.
6. 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:

1. Treatment of NAFLD for at least 3 months prior to the screening.
2. History of decompensated liver disease (ascites, encephalopathy, variceal bleeding).
3. Participants with liver cirrhosis, any concomitant liver disease.
4. Participants with systemic inflammatory disease or autoimmune disorders.
5. 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).
6. Participants with Fasting blood glucose Less than or equal to 140 mg/ dl.
7. Participants with cardiopulmonary disease.
8. 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
9. Participants with liver cancer - primary hepatocellular carcinoma or liver metastasis.
10. Participants with other systemic disorders of the heart, lungs, blood, and endocrine system, including thyroid dysfunction and Type I diabetes mellitus.
11. Histologic evidence of NASH with fibrosis stage (METAVIR score) F1 or F4.
12. Individuals with Inflammatory bowel diseases.
13. Use of medications containing systemic steroids, methotrexate corticosteroids, amiodarone, tamoxifen, valproate, vitamin E, omega-3, Anti-retroviral agents; 1 month prior to screening.
14. 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.
15. Participants who have hypersensitivity to the test drug/ placebo or components contained in the test drug/placebo or have severe allergic reactions.
16. Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
17. Regular use of a probiotic or prebiotic supplement within 3 months prior to screening.
18. Antibiotic use within 3 weeks prior to screening.

Primary outcomes:
measure: Fibroscan
timeFrame: Day 120.
Secondary outcomes:
measure: AST & ALT
timeFrame: Day 0, 60 and 120
measure: Lipid Profile
timeFrame: Day 0, 60 and 120
measure: Inflammatory markers
timeFrame: Day 0 and 120
measure: serum Lipopolysaccharide level
timeFrame: Day 0 and 120
measure: Fibroscan
timeFrame: [Time Frame: Day 0, Day 60 and Day 120
Other outcomes:
Locations:
city: Jaipur
country: India
facility: JNU institute of medical science and research
state: Rajashthan
city: Jaipur
country: India
facility: Dr. Sudhir Maharshi Gastro clinic
state: Rajasthan
Study officials:
affiliation: Dr. Sudhir Maharshi Gastro clinic
name: Dr. Sudhir Maharshi, MBBS DNB Gastro
role: PRINCIPAL_INVESTIGATOR
References: