Probiotic Supplementation on Weight Loss
Primary Purpose
Bariatric Surgery Candidate
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Probiotic
microcrystalline cellulose
Sponsored by
About this trial
This is an interventional supportive care trial for Bariatric Surgery Candidate focused on measuring Probiotic, Microbiome
Eligibility Criteria
Inclusion Criteria:
- All subjects who are > 18 and < 65 years of age recruited from the Mayo Clinic bariatric surgery clinic
- Will also 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.
Exclusion Criteria:
- 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 peri-operative antibiotics (cefazolin and metronidazole) will be excluded.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Probiotic
Placebo
Arm Description
This arm will be receiving probiotic supplements.
This arm will be receiving placebo containing microcrystalline cellulose.
Outcomes
Primary Outcome Measures
Weight loss
Change in body weight from baseline to 3 months
Visceral fat loss
Change in visceral fat from baseline to 3 months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03832439
Brief Title
Probiotic Supplementation on Weight Loss
Official Title
The Effect of Probiotic Supplementation on Weight Loss, and Its Association With the Gut Microbiome After Bariatric Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
April 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators are trying to better understand how bariatric surgery leads to weight loss, and the role of bacteria that live in the gut in making this happen.
Detailed Description
The investigators are interested in seeing how a probiotic, which is a dietary supplement containing large amounts of 'good' bacteria, can influence the make-up of the gut bacterial population and what effect it has on weight loss and loss of fat. Before undergoing weight loss surgery (sleeve gastrectomy or roux-en-y gastric bypass), study participants will be asked to provide a stool sample to assess the make-up of their gut bacterial population. They will also undergo a limited CT scan of the abdomen and DEXA (Xray) to help assess the amount of fat present inside the body.
After undergoing weight loss surgery (sleeve gastrectomy or roux-en-y gastric bypass), study participants will be given either a probiotic supplement or dummy pill (placebo) for 3 months, in addition to all usual care that occurs after surgery. The CT scan, DEXA scan and stool sample will be repeated at the end of the 3 month period and analyzed for changes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate
Keywords
Probiotic, Microbiome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
This arm will be receiving probiotic supplements.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This arm will be receiving placebo containing microcrystalline cellulose.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Other Intervention Name(s)
Culturelle®
Intervention Description
Lactobacillus rhamnosus GG 10 billion cells and microcrystalline cellulose
Intervention Type
Dietary Supplement
Intervention Name(s)
microcrystalline cellulose
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Weight loss
Description
Change in body weight from baseline to 3 months
Time Frame
3 months
Title
Visceral fat loss
Description
Change in visceral fat from baseline to 3 months
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All subjects who are > 18 and < 65 years of age recruited from the Mayo Clinic bariatric surgery clinic
Will also 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.
Exclusion Criteria:
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 peri-operative antibiotics (cefazolin and metronidazole) will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meera Shah, M.B., Ch.B
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Probiotic Supplementation on Weight Loss
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