A Study of the Effect of Probiotic Supplements on Weight Loss, and the Connection it has to the Bacterial Environment of the Digestive System after Bariatric Surgery

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-003300
    Sponsor Protocol Number: 16-003300

About this study

The purpose of this study is to assess the associated effects of probiotic supplements on weight loss, visceral and total body fat, and changes in the biological environment of the digestive tract in patients who have had bariatric surgery.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria                                           

  • > 18 and < 65 years of age
  • Recruited from the Mayo Clinic bariatric surgery clinic
  • Meets one of the National Institute of Health’s criteria for bariatric surgery
    • Body mass index (BMI) > 40 kg/m2 
    • BMI > 35 kg/m2 with significant weight-related comorbidities
  • Is not on chronic antibiotic therapy        
  • Does not have active systemic illness

Exclusion Criteria

  • Type 1 or 2 diabetes due to the known pre-existing changes in the gut microbiome in this population
  • Has had exposure to probiotics, prebiotics or antibiotics in the preceding 4 weeks
  • Has an allergy to antibiotics precluding the use of standard peri-operative antibiotics cefazolin and metronidazole

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Meera Shah, M.B., Ch.B.

Open for enrollment

Contact information:

Paula Giesler R.N.

(507)255-8345

Giesler.Paula@mayo.edu

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CLS-20258286

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