Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Fecal Microbiota Transplantation and Diet and Exercise: Fecal Microbiota transplantation and Diet and Exercise
Duration: 1 month
Control Intervention1: Diet and Exercise: Diet and Exerc
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients posted for Upper GI endoscopy for other indications 2. 18- 55 yrs of age with NAFLD and 3. BMI 4. Body Mass Index (BMI) is 5. Ambulatory and able to perform the ILBS healthy lifestyle (diet and exercise program). 6. Failed to life style therapy
Exclusion criteria
Exclusion criteria: 1. HIV, HBsAg or HCV positive 2. Prior bariatric surgery 3. Change in weight of 4. Malignancy within 5 years 5. Recent major surgery; history of seizure disorder 6. Depression or other major psychiatric disease within 2 years requiring treatment with prescription medication 7. Pregnancy or lactation 8. Significant uncontrolled cardiopulmonary diseases 9. Major surgical procedure (intrathoracic, intracranial, intraperitoneal, liposuction) within 6 months of screening 10. Hypo or hyperthyroidism uncontrolled. If initiation or adjustment of doses of these drugs is anticipated, patients should not be enrolled. 11. Patients being treated for hypothyroidism must be adequately replaced on a stable dose of medication for at least 3 months prior to screening. 12. Uncontrolled DM with HbA1c greater than 9%. 13. Recent treatment (i.e., within 1 month of the screening visit) with weight drugs or products or appetite suppressants (including herbal weight agents) 14. Recent treatment (i.e., within 3 months of the screening visit) with oral or parenteral corticosteroids 15. Recent history (within 2 years prior to the screening visit) of significant alcohol use 16. Significant change in diet or level of physical activity within 1 month prior to enrolment 17. Use of very-low calorie ( < 1,000/day) liquid weight diet within 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving â?¤ 5%of the weight loss in kg from baselineTimepoint: 3 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in body compositionTimepoint: 3,6 and 1 year;Changes in faecal microbiomeTimepoint: 3,6 and 1 year;Changes in Fasting glucose, insulin & HBa1C and the homeostasis model assessment of insulin resistanceTimepoint: 3,6 and 1 year;Changes in fibroscan and CAP valuesTimepoint: 6 and 1 year;Changes in High-sensitivity C-reactive protein, fibrinogen TNF-alpha.Timepoint: 3, 6 and 12 months;Changes in quality of lifeTimepoint: 3,6 and 1 year;Changes in systolic and diastolic BPTimepoint: 3,6 and 1 year;Changes in Total cholesterol, LDL cholesterol, and triglyceride levelsTimepoint: 3,6 and 1 year;Changes in waist circumference and waist hip ratioTimepoint: 3,6 and 1 year;Proportion of patients achieving â?¤ 5% of the weight loss in kg from baselineTimepoint: 6 and 12 months | — |
Countries
India
Contacts
Public ContactDr Manoj Kumar Sharma
Institute of Liver and Biliary Sciences
Outcome results
None listed