Ignite Creation Date:
2024-05-06 @ 12:44 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03832439
Status:
COMPLETED
Last Update Posted:
2022-02-21
First Post:
2019-02-04
Brief Title:
Probiotic Supplementation on Weight Loss
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
The Effect of Probiotic Supplementation on Weight Loss and Its Association With the Gut Microbiome After Bariatric Surgery
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None