Effect of FMT (stool therapy) on weight in NAFLD (Liver Disease)
- Conditions
- Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
- Registration Number
- CTRI/2020/09/028028
- Lead Sponsor
- Institute of Liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients achieving â?¤ 5%of the weight loss in kg from baselineTimepoint: 3 Months
- Secondary Outcome Measures
Name Time Method 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