Probiotic Supplementation on Weight Loss
The Effect of Probiotic Supplementation on Weight Loss, and Its Association With the Gut Microbiome After Bariatric Surgery.
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2019
CompletedFirst Submitted
Initial submission to the registry
February 4, 2019
CompletedFirst Posted
Study publicly available on registry
February 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2021
CompletedFebruary 21, 2022
February 1, 2022
2.3 years
February 4, 2019
February 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Weight loss
Change in body weight from baseline to 3 months
3 months
Visceral fat loss
Change in visceral fat from baseline to 3 months
3 months
Study Arms (2)
Probiotic
ACTIVE COMPARATORThis arm will be receiving probiotic supplements.
Placebo
PLACEBO COMPARATORThis arm will be receiving placebo containing microcrystalline cellulose.
Interventions
Lactobacillus rhamnosus GG 10 billion cells and microcrystalline cellulose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meera Shah, M.B., Ch.B
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 4, 2019
First Posted
February 6, 2019
Study Start
January 17, 2019
Primary Completion
April 28, 2021
Study Completion
April 28, 2021
Last Updated
February 21, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share