A Clinical Trial to Evaluate the Efficacy and Safety of MXP22 on Liver Health

NCT05808049 | Completed

• 1 other identifier: SY/211203/MASP/NFLD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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

  Day 120.

Secondary Outcomes (5)

• AST & ALT

  Day 0, 60 and 120

• Lipid Profile

  Day 0, 60 and 120

• Inflammatory markers

  Day 0 and 120

• serum Lipopolysaccharide level

  Day 0 and 120

• Fibroscan

  [Time Frame: Day 0, Day 60 and Day 120

Study Arms (2)

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

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

Other: Placebo (Microcrystalline Cellulose)

Interventions

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

MXP22 (Probiotic and antioxidant capsule)

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

Placebo (Microcrystalline Cellulose )

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (2)

JNU institute of medical science and research

Jaipur, Rajashthan, 302017, India

Location

Dr. Sudhir Maharshi Gastro clinic

Jaipur, Rajasthan, 302001, India

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Probiotics; Antioxidants; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals

Study Officials

• Dr. Sudhir Maharshi, MBBS DNB Gastro

  Dr. Sudhir Maharshi Gastro clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Sequentially numbered, sealed, opaque envelopes
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Parallel Group, Placebo Controlled Trial

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: April 11, 2023
• Study Start: October 6, 2022
• Primary Completion: July 4, 2023
• Study Completion: July 4, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

IN (2)