Effects of Fecal Microbiota Transplantation on Weight in Obese Patients With Non-alcoholic Fatty Liver Disease: A Pilot Randomized Controlled Trial

Institute of Liver and Biliary Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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

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