514 4 Inflammatory markers C reactive protein CRP Tumor necrosis factor \u03b1 TNF \u03b1

514 4 inflammatory markers c reactive protein crp

This preview shows page 6 - 8 out of 37 pages.

Version 5/4.5.14 4. Inflammatory markers (C reactive protein (CRP), Tumor necrosis factor α (TNF-α), Interleukin 6 (IL6), IL10, Tumor growth factor β (TGF-β)), adipocytokines (leptin, adiponectin), endotoxin (Lipopolysacchride (LPS)) and hepatocyte apoptosis markers (Caspase-generated cytokeratin-18 (CK-18), sFas) 5 . The fecal microbiota composition 6 . Bacterial overgrowth (BO ( 7 . Quality of life (QoL ( 8 . Food tolerance after bariatric surgery 3a. Research hypothesis of the randomized clinical trial 3a.1 Primary research hypothesis: Superiority of the probiotic arm over the control arm (placebo) in improving all the measured parameters after the surgery (anthropometric, biochemical, Quality of life, etc .( 1 . The HRI score will be reduced in the probiotic arm (intervention arm) as compared to the control arm . The abdominal US will indicate a higher rate of complete regression of fatty liver in the probiotic arm as compared to the control arm . 3a.2 Secondary research hypothesis : 1. The Fibroscan test will indicate a higher rate of regression of liver fibrosis in the probiotic arm as compared to the control arm after the surgery. 2. The anthropometric measurements (% EWL, BMI, WC and %fat mass) will improve to a greater extent in the probiotic arm as compared to the control arm following the surgery. 3. Serum levels of liver enzymes after the surgery will be reduced to a greater degree in the probiotic arm as compared to the control arm. There will be higher serum levels of vitamin B12 in the probiotic arm as compared to the control arm after the surgery. 4. Serum levels of inflammatory markers, endotoxin (LPS) and hepatocyte apoptosis markers after the surgery will be reduced to a greater degree in the probiotic arm as compared to the control arm. 5. There will be changes in the microbiota composition in the probiotic arm as compared to the control arm after the surgery. 6. The rate of BO will be lower in the probiotic arm as compared to the control arm after the surgery. 7. The QoL questionnaire will show higher scores in the probiotic arm as compared to the control arm after the surgery. 8. There will be higher score for food tolerance questionnaire after bariatric surgery in the probiotic arm as compared to the control arm after the surgery. 6
Image of page 6
Version 5/4.5.14 4. Importance of the study: The gut microbiota plays a crucial role in numerous conditions associated with obesity and other metabolic diseases. Recent studies show that modulation of gut microbiota may represent a novel way to treat or prevent NAFLD and its progression. Among patients undergoing bariatric surgery, as many as 96% have NAFLD and up to 40% have NASH. Bariatric surgery is associated with major modifications in microbiota composition, quantity and function. Potential mediators to the gut microbiota are probiotics, which are considered to be safe therapy because the microorganisms they contain are found naturally in human microflora. To date, there is lack of evidences on the use of probiotics in bariatric surgeries (just 1 RCT in RYGB patients) and more trials are needed.
Image of page 7
Image of page 8

You've reached the end of your free preview.

Want to read all 37 pages?

  • Fall '16
  • Jeff Miller

  • Left Quote Icon

    Student Picture

  • Left Quote Icon

    Student Picture

  • Left Quote Icon

    Student Picture

Stuck? We have tutors online 24/7 who can help you get unstuck.
A+ icon
Ask Expert Tutors You can ask You can ask You can ask (will expire )
Answers in as fast as 15 minutes