Effect of probiotic in the management of nonalcoholic fatty liver disease

Phase 2

• Conditions: Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

• Registration Number: CTRI/2024/01/062024
• Lead Sponsor: nique Biotech Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Early diagnosis of NAFLD grading 1 2or 3 on abdominal ultrasound

Mild to moderate elevation of serum aminotransferase levels

Treatment naïve patients or patients not on any treatment for at least 4 weeks before inclusion

Patients with a body mass index between 25 and 40 kg per square meter

Patients with a history of controlled obesity or controlled diabetes

Exclusion Criteria

Patients with an unstable metabolic condition such as weight change of more than 5 percent in the 3 months prior to inclusion

Patients with medical history of gastric bypass surgery or orthotopic liver transplant

Patients with uncontrolled diabetes mellitus type 2 at the time of screening

Patients with decompensated or severe liver disease as evidenced by one or more of the following, confirmed cirrhosis or suspicion of cirrhosis, esophageal varices, ascites, suspicion of portal hypertension, hospitalization for liver disease within 60 days of screening.

Patients with inflammatory bowel disease

Patients with diagnosed or suspected autoimmune diseases

Patients with a history of or active non liver malignancies

Patients with a significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal insufficiency, serious psychiatric disease, respiratory or hypertensive disease, as well as diabetes and arthritis

Patients requiring anti-diabetic treatment or lipid lowering treatment

If patients are insulin dependent this treatment should have commenced at least 3 months prior to screening however changes in dose are permitted.

Patients with known hypersensitivity to any ingredients of the study treatment.

Patients with a positive test for human immunodeficiency virus antibodies, Hepatitis B surface antigen or Hepatitis C antibodies at screening.

Patients with liver disease of other etiologies such as drug induced, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, haemochromatosis, alpha1 antitrypsin deficiency or Wilsons disease.

Patients with a significant history of drug or alcohol abuse

Patients who have used dietary supplements rich in omega 3 or omega 6 fatty acids, probiotics, homeopathic or herbal drugs in the 4 weeks prior to baseline.

Patients who have participated in any other clinical study with an investigational drug within 3 months

Patients who are pregnant, planning pregnancy, breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified