Effects of Fecal Microbiota Transplantation on Weight in Obese Patients With Non-alcoholic Fatty Liver Disease

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Oct 14, 2020

Keywords

ClinConnect Summary

Aim \&Objectives.

Hypothesis • Null Hypothesis: There is no difference between the Lean donor Faecal microbiota transplantation and no Faecal microbiota transplantation as regards to weight loss in obese persons with Non-alcoholic fatty liver disease

• Alternate hypothesis: Lean donor Faecal microbiota transplantation will lead to greater weight loss in obese persons with Non-alcoholic fatty liver disease as compared to no faecal microbiota transplantation in obese persons with Non-alcoholic fatty liver disease

AIM: Effects of Fecal Microbiota Transplantation on Weight in Obese Patients ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients posted for Upper GI endoscopy for other indications
• • 2. 18- 55 yrs of age with NAFLD and
• • 3. BMI ≤ 35 or
• • 4. Body Mass Index (BMI) is ≤30 to 34.9 kg/m2 with at least one treated or untreated comorbid condition (hypertension, dyslipidaemia, cardiovascular disease, glucose intolerance, sleep apnoea, NASH).
• • 5. Ambulatory and able to perform the ILBS healthy lifestyle (diet and exercise program).
• • 6. Failed to life style therapy.
• Exclusion Criteria:
• • 1. HIV, HBsAg or HCV positive
• • 2. Prior bariatric surgery
• • 3. Change in weight of ≤5 % within 3 months
• • 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