Effects of Fecal Microbiota Transplantation on Weight in Obese Patients With Non-alcoholic Fatty Liver Disease: A Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 110
- Locations
- 2
- Primary Endpoint
- Proportion of patients achieving ≤ 5%of the weight loss in kg from baseline
Study Overview
Brief Summary
The worldwide impact of obesity suggests an urgent need for solutions to decrease its burden on modern society. It has been generally understood that obesity is caused by a simple imbalance in the intake of energy in the form of food compared with the expenditure of energy by the body the human microbiota consists of a wide variety of microorganisms, including bacteria, archaea, fungi, viruses, protozoans and yeast. These organisms colonize both the exterior and interior of the human body in numbers that are equivalent to those of human cells of their host. Current research has identified numerous physiological and psycho-modulatory functions of the gut microbiota, including digesting food, stimulating cell growth, strengthening the immune system, preventing allergies and diseases, and impacting emotion. The gut microbiota can contribute to host physiology through metabolite production, such as short-chain fatty acids (SCFAs), which can modulate the intestinal barrier and inflammation 9.Dysbiosis of the gut microbiota, defined as a decrease in commensal bacteria levels and diversity, has been linked to diseases such as stomach/colon/liver cancer 2, obesity 9,inflammatory bowel disease (IBD) and anxiety.
Detailed Description
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 with Non-Alcoholic Fatty Liver Disease: A Pilot Randomized Controlled Trial.
FMT Technique:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients posted for Upper GI endoscopy for other indications
- •18- 55 yrs of age with NAFLD and
- •BMI ≤ 35 or
- •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).
- •Ambulatory and able to perform the ILBS healthy lifestyle (diet and exercise program).
- •Failed to life style therapy.
Exclusion Criteria
- •HIV, HBsAg or HCV positive
- •Prior bariatric surgery
- •Change in weight of ≤5 % within 3 months
- •Malignancy within 5 years
- •Recent major surgery; history of seizure disorder
- •Depression or other major psychiatric disease within 2 years requiring treatment with prescription medication
- •Pregnancy or lactation
- •Significant uncontrolled cardiopulmonary diseases
- •Major surgical procedure (intrathoracic, intracranial, intraperitoneal, liposuction) within 6 months of screening
- •Hypo or hyperthyroidism uncontrolled. If initiation or adjustment of doses of these drugs is anticipated, patients should not be enrolled.
- •Patients being treated for hypothyroidism must be adequately replaced on a stable dose of medication for at least 3 months prior to screening.
- •Uncontrolled DM with HbA1c greater than 9%.
- •Recent treatment (i.e., within 1 month of the screening visit) with weight drugs or products or appetite suppressants (including herbal weight agents)
- •Recent treatment (i.e., within 3 months of the screening visit) with oral or parenteral corticosteroids
- •Recent history (within 2 years prior to the screening visit) of significant alcohol use
- •Significant change in diet or level of physical activity within 1 month prior to enrolment
- •Use of very-low calorie (< 1,000/day) liquid weight diet within 6 months
Outcomes
Primary Outcomes
Proportion of patients achieving ≤ 5%of the weight loss in kg from baseline
Time Frame: 3 months
Secondary Outcomes
- Changes in Fasting glucose in both groups(1 year)
- Changes in HbA1C in both groups(1 year)
- Proportion of patients achieving ≤ 5% of the weight loss in kg from baseline(12 months)
- Changes in insulin in both groups(1 year)
- Changes in systolic and diastolic BP(1 year)
- Changes in LDL cholesterol in both groups(1 year)
- Changes in High-sensitivity C-reactive protein in both groups(1 year)
- Change in TNF alpha in both groups(12 months)
- Changes in faecal microbiome in both groups(1 year)
- Changes in body composition in both groups(1 year)
- Changes in waist circumference and waist hip ratio(1 year)
- Changes in Total cholesterol in both groups(1 yera)
- Changes in Triglyceride levels in both groups(1 year)
- Change in Fibrinogen in both groups(12 months)
- Changes in fibroscan values in both groups(12 months)
- Changes in CAP values in both groups(12 months)
- Changes in quality of life in both groups(1 year)
- Changes in homeostasis model assessment of insulin resistance in both groups(1 year)