Bariatric Times

APR 2017

A peer-reviewed, evidence-based journal that promotes clinical development and metabolic insights in total bariatric patient care for the healthcare professional

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20 Research Bites Bariatric Times • April 2017 FECAL MICROBIOTA TRANSPLANTATION FOR THE TREATMENT OF OBESITY (FMT OBESITY) Status: This study is currently r ecruiting participants. Purpose: This is a randomized controlled pilot study to assess the microbiological and clinical impacts of Fecal Microbiota Transplantation (FMT) in patients with obesity. The investigators will prospectively enroll 20 adult patients who are obese (Body Mass Index of 35kg/m2 or higher) after providing written informed consent. The study participants will be randomized 1:1 to either the treatment arm or the placebo arm. The treatment arm will receive an induction FMT with capsules followed by a monthly maintenance dose of oral capsules for 12 weeks total. The placebo group will receive a placebo capsules for induction followed by monthly intake of oral placebo capsules for 12 weeks. Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator, Outcomes Assessor Primary Purpose: Treatment Eligibility: • Ages Eligible for Study: 18 Years and older (Adult, Senior) • Sexes Eligible for Study: All • Accepts Healthy Volunteers: No Criteria: Inclusion Criteria: -Age 18 years or older -Obesity defined as a BMI of 35kg/m2 or higher Exclusion Criteria: -Triglycerides > 500 mg/dL -Use of antibiotics <8 weeks prior to participation -Use of probiotics <4 weeks prior to participation -Alcohol use of greater than 20g/daily or suspicion of alcohol abuse and dependence -Substance abuse, current -LFTS greater then 3x the ULN -Cirrhosis. -DM type 2 that is insulin d ependent, treated with GLP1- agonists, or poorly controlled on oral medications (HbA1C > 10%) -Use of any weight loss medication or participation in a weight loss s tudy or program such as Weight Watchers -History of recent weight change (weight loss or weight gain in the two months preceding trial enrollment). This is defined as a gain or loss of 10 or more pounds in the preceding 2 months -Patients who are pregnant or breastfeeding -Patients who are unable to give informed consent -Patients who have previously undergone FMT -Patients who have a confirmed malignancy or cancer -Patients who are immunocompromised -Participation in a clinical trial in the preceding 30 days or simultaneously during this trial -Previous gastric or small intestinal surgery that alters gut anatomy such as fundoplication, gastric resection, gastric bypass, small bowel resection, and ileocectomy -Other comorbidities including: systemic lupus, inflammatory bowel disease, or Chronic kidney disease as defined by a GFR <60mL/min/1.73m2 44 -History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia -Any condition, based on clinical judgment that may make study participation unsafe -History of severe food allergies -Use of immune modulators including methotrexate, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, Interleukin-10, or Interleukin-11 -Treatment with infliximab, adalimumab, certolizumab, natalizumab, vedolizumab or thalidomide -Congenital or acquired immunodeficiencies Primary Outcome Measures: • Safety of fecal microbiota transplantation (FMT) as m easured by number and nature of adverse events within 52 weeks of FMT [ Time Frame: 1 year ] • Adverse event (AE) is defined as any untoward medical occurrence i n a clinical investigation patient administered a biologic product. It is an unintended sign, symptom, or disease temporally associated with the use of the investigational agent. Adverse events will be determined by a toxicity grading scale. Sponsors and Collaborators: • Brigham and Women's Hospital, Boston, Massachusetts ClinicalTrials.gov identifier: NCT02741518 PHYSICAL ACTIVITY, SEDENTARY AND ENERGY CONSUMPTION AFTER BARIATRIC SURGERY Status: This study is currently recruiting participants. Purpose: This study aims to examine the energy consumption before and after bariatric surgery. The study will contribute to the knowledge if operations should be complemented by interventions to increase energy expenditure, mainly by reducing sedentary. Such intervention should be based on knowledge of the mediators of physical activity among the subjects that need to be strengthened. Study Type: Observational Study Design: Observational Model: Case-Only Time Perspective: Prospective Eligibility: • Ages Eligible for Study: Child, Adult, Senior • Sexes Eligible for Study: All • Accepts Healthy Volunteers: No • Sampling Method: Non-Probability Sample • Study Population: Patients undergoing bariatric surgery Criteria: Inclusion Criteria: -All patient at Lindesbergs hospital that get bariatric surgery (a limit to get the surgery is BMI above 35) Exclusion Criteria: -Not understanding Swedish or English -Not the first bariatric surgery P rimary Outcome Measures: • Calories consumed [Time Frame: one year after surgery] Amount calories consumed per day • Hours sedentary [Time Frame: one y ear after surgery ] Hours sedentary during a day Secondary Outcome Measures: • Mediators of physical activity [Time Frame: one year after surgery] • Self-efficacy, social support, and enjoyment of physical activity measured by questionaires Sponsors and Collaborators: Region Örebro County, Örebro, Sweden ClinicalTrials.gov identifier: NCT02938338 EFFECTS OF ALCOHOL AFTER BARIATRIC SURGERY (RBA) Status: This study is not yet open for participant recruitment. Purpose: The investigators wish to study the effects of three forms of bariatric surgery: gastric bypass, sleeve gastrectomy, and lap banding. The surgery is not part of the clinical trial. If insurance does not cover the procedure, then the patient is responsible for payment of the surgical process. The investigators are doing pre- and post-surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight loss on 1) alcohol absorption, distribution and elimination from the body; 2) the effects of alcohol on blood sugar; and 3) the effects of alcohol on mood. Study Type: Observational Study Design: Observational Model: Other Time Perspective: Other Eligibility: • Ages Eligible for Study: 21 Years to 65 Years (Adult) • Sexes Eligible for Study: Female • Accepts Healthy Volunteers: Yes • Sampling Method: Non-Probability Sample • Study Population: Bariatric surgery clinic Criteria: Inclusion Criteria: -Women -Drink alcohol at least once per Clinical Trials in Bariatric and Metabolic Medicine Information provided from clinicaltrials.gov Research Bites

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