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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.
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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:
Stool Donor Criteria A healthy single donor will be identified who will be the universal donor for all patients enrolled in the study.
The donor will be screened for
Donor will be excluded if he/she has:
Stool donor procedure:
Stool Collection and Preparation:
Stool Administration Procedure (ILBS FMT Protocol)
Post-Procedure Advice and Management
DIET AND EXERCISE PROGRAMME AND ASSESSMENT OF COMPLIANCE:
Dietary Intervention:
A high-protein low carbohydrate diet (HPLC) diet would be prescribed to the patients. HPLC (high-protein low carbohydrate) diet would comprise of energy as 20-25 Kcal/Kg IBW/day (amounting to 700- 800 Kcal less than the usual dietary intake), Protein as 1.2-1.5 gm/Kg IBW/day i.e. 30% of the total calories as proteins, 52% of carbohydrates 18% of fats with dietary fiber as 25 g/day. The protein requirements would be met with modular high protein, low calorie supplements25,26.
Physical Activity:
The exercise program would consist of brisk walking. Brisk walking is defined as the walking intensity of 60-70% of their respective age-predicted maximum heart rate (target heart rate) 27,28. Speed of 5- 6 kmph considered as a brisk walking in most of the studies preferably on a treadmill for a duration of 30-45 minutes30 or brisk walking (walking faster than normal pace, measure 5000 steps continuously by pedometer). Same amount of physical activity would be prescribed to both the groups for 5 days a week for 30 -45 min
Duration of Intervention: This diet and exercise regimen would be implemented for a period of 6months
Assessment of Compliance- Following measures would be taken to ensure the compliance of the patients-
Amount of food is going to based upon each individual. We will give diet chart to every individual; we will explain to each individual in details regarding the benefits of protein low carbohydrate and the importance of the quantification of the diet. Regarding the scale of compliance, it is validated and used also and I have attached the questionnaires in the Performa. Exemplary diet chart also attached in the Performa.
Physical activity compliance: -
FOLLOW-UP OF PATIENTS [AT BASELINE, 3 MO, 6 MO AND 12 MO].
Life style failure is defined as Dietary therapy should ensure an intake reduced by 500 to 1,000 kcal/day from the current level. Low calorie diets (LCDs) containing 1,000 to 1,200 kcal/day for most women and between 1,200 kcal/day and 1,600 kcal/day for men. Physical activity (walking, dancing, gardening, household chores and team or individual sports) should be increased slowly to a level that ensures at least 30 minutes or more of moderate-intensity physical activity on most, and preferably all, days of the week for 6 months could not reduce weight by 5 % labeled as life style failure.
Body Weight: - electronic weighing machine.
Waist and Hip Measurements :- the waist circumference should be measured at the midpoint between the lower margin of the last palpable ribs and the top of the iliac crest, using a stretch-resistant tape that provides a constant 100 g tension. Hip circumference should be measured around the widest portion of the buttocks, with the tape parallel to the floor. 14
Clinical Laboratory Assessments. Insulin resistance (HOMA-IR): - (Insulin resistance (HOMA-IR): - fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.) and insulin is getting measured by A chemiluminescent immunoassay (CLIA) 15 is commonly used in our laboratories for measurement of insulin concentration in our samples.
High-sensitivity C-reactive protein, fibrinogen TNF-alpha, adiponectin, leptin, Ghrelin.: - they are measured with the special ELISA kit.
Gut microbiome analysis methods: - This technique allows the rapid sequencing of multiple samples at one time, yielding thousands of sequences reads per sample. Specifically, we generated a set of 96 emulsion polymerase chain reaction (PCR) fusion primers that contain the 454 emulsion PCR linkers on the 27F primer (AGAGTTTGATCCTGGCTCAG-3=) and 355R' (5=-GCTGCCTCCCGTAGGAGT-3=) and different 8-base barcode between the A adapter and the 27F primer.8 Thus, each faecal sample was amplified with unique bar-coded forward 16S ribosomal RNA primers, and then up to 96 samples were pooled and subjected to emulsion PCR and pyro sequenced. 16
Serum transcriptome: - Transcriptomics technologies are the techniques used to study an organism's transcriptome, the sum of all of its RNA transcripts. The information content of an organism is recorded in the DNA of its genome and expressed through transcription. Here, mRNA serves as a transient intermediary molecule in the information network, whilst noncoding RNAs perform additional diverse functions. A transcriptome captures a snapshot in time of the total transcripts present in a cell. The first attempts to study the whole transcriptome began in the early 1990s, and technological advances since the late 1990s have made transcriptomics a widespread discipline. Transcriptomics has been defined by repeated technological innovations that transform the field. There are two key contemporary techniques in the field: microarrays, which quantify a set of predetermined sequences, and RNA sequencing (RNA-Seq), which uses high throughput sequencing to capture all sequences. 17
Body composition analysis method: - common assessments are anthropometric and include weight, stature, abdominal circumference, and skinfold measurements. 18 Assessment of compliance to diet and exercise programme: - by the number of questionnaires asked during each visit of patient in the hospital.
Stool sample for microbiome analysis will be collected on day 0,7, 90 and 180. All the adverse effects will be monitored and notified.
Study population: 18- 55 yrs of age with NAFLD and
Attended hepatology OPD. Study design: Randomized controlled trial Study period: One year from ethics approval. Sample size: 110 (55 cases in each group) Intervention: The subjects will be given FMT through UGI endoscopy. They will be administered the processed fecal microbiota sample collected from lean healthy donor for a period of 0/15/30 days.
FOLLOW-UP OF PATIENTS [AT BASELINE, 3 MO, 6 MO AND 12 MO]
Adverse effects: diarrhea, pneumonia, abdominal pain, constipation, nausea vomiting, fever and death Stopping rule: In the event of any of the adverse effects during therapy.
Ethical issues in the study and plans to address these issues: None
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110 participants in 2 patient groups
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Dr Pinakee Sunder Kar, MD
Data sourced from clinicaltrials.gov
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