Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients will be randomized into 2 groups:
Weight loss will be assessed 1 year after surgery
Patients will be randomized into 2 groups:
Preoperative probiotics scheme include:
Postoperative probiotics scheme include:
Both groups will receive the same nutritional recommendations.
1 year after surgery, weight los will be assessed as primary outcome. Secondary outcomes will include daibetes mellitus remission and dyslipidemia remission.
Weight loss will be assessed 1 year after surgery
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Experimental | Patients will receive the previously mentioned combination of probiotics pre- and postoperatively |
|
| No probiotics | No Intervention | Patients will not receive probiotics |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of probiotics | Biological | Patients will receive the previously mentioned combination of probiotics before and after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Weight loss will be assessed as excess body mass index (BMI) loss, calculated by the formula: Excess BMI loss= (preoperative BMI-postoperative BMI)/ (preoperative BMI-25) | 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Remission of diabetes mellitus | Remission of diabetes mellitus will be defined as fasting glucose <100mg/dl and glycated hemoglobin <6% at blood sample | 1 year after surgery |
| Remission of dyslipidemia |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaime Ruiz-Tovar | Contact | +34630534808 | jruiztovar@gmail.com | |
| Carolina Llavero | Contact | +37649593020 | carolinallavero@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gilberto Gonzalez | Hospital Angeles del Carmen, Guadalajara, Mexico | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Remission of dyslipidemia will be defined as triglycerids <200mg/dl, total cholesterol<200mg/dl and HDL-colesterol >45mg/dl at blood sample
| 1 year after surgery |