This study is looking to assess the role of a probiotic, which is a dietary supplement containing ‘good’ bacteria, in influencing the gut and impacting weight loss in bariatric surgery patients. Before surgery, participants will provide stool samples and undergo a CT scan and Xray. After surgery, participants will either be given a probiotic or placebo and, after 3 months, the initial stool sample and scans will be repeated and analyzed for changes.
This is an interventional, non-randomized trial of approximately 40 participants. It began on January 17th 2019 and is estimated to conclude on June 15th 2020.
- All subjects who are over 18 and under 65 years of age recruited from the Mayo Clinic bariatric surgery clinic
- Must meet one of the National Institute of Health’s criteria for bariatric surgery, i.e. body mass index (BMI) > 40 kg/m2 or BMI > 35 kg/m2 with significant weight-related comorbidities.
- Patients will be eligible if they are not on chronic antibiotic therapy and without active systemic illness.
- Patients with type 1 or 2 diabetes will be excluded due to the known pre-existing changes in the gut microbiome in this population. All patients will not have had exposure to probiotics, prebiotics or antibiotics in the preceding 4 weeks.
- Patients with allergy to antibiotics precluding the use of standard perioperative antibiotics (cefazolin and metronidazole).
This study is taking place at the Mayo Clinic. Rochester, Minnesota, United States, 55905. For more information, please contact Vishakantha Murthy, PhD on 507-255-8112 or at Murthy.Vishakantha@mayo.edu.
Sponsors and Collaborators
This study is sponsored by the Mayo Clinic, with Meera Shah, M.B., Ch.B as the Principal Investigator.
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