Pre- and Postoperative Probiotics Administration in Patients Undergoing Sleeve Gastrectomy

Study Overview
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Brief Summary
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Patients will be randomized into 2 groups: G1: Patients undergoing sleeve gastrectomy as bariatric procedure and receiving pre- and postoperative probiotics G2: Patients undergoing sleeve gastrectomy as bariatric procedure and not receiving pre- or postoperative probiotics Weight loss will be assessed 1 year after surgery

Detailed Description
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Patients will be randomized into 2 groups: G1: Patients undergoing sleeve gastrectomy as bariatric procedure and receiving pre- and postoperative probiotics G2: Patients undergoing sleeve gastrectomy as bariatric procedure and not receiving pre- or postoperative probiotics Preoperative probiotics scheme include: saccharomyces boulardii ntc 5375 + enterococcus faecium UBEF-41 + lactobacillus acidophilus LA 14 during 15 days (between 6th and 4th weeks before surgery) Bifidobacterium lactis BL 04 + Bifidobacterium breve BB 03 + Bifidobacterium bifidum BB 06 + Bifidobacterium longum BL 05 during 15 days (between 4th and 2nd weeks before surgery) lactobacillus rhamnosus LR 32 + lactobacillus rhamnosus HN001 + lactobacillus acidophillus LA 14 during 15 days (between 2nd week and the day before surgery) Postoperative probiotics scheme include: saccharomyces boulardii ntc 5375 + enterococcus faecium UBEF-41 + lactobacillus acidophilus LA 14 during 15 days (between 1st and 3rd weeks after surgery) Lactobacillus rhamnosus LR 32 + Bifidobacterium lactis BL 04 + Bifidobacterium longum BL 05 + lactobacillus salivarius LS 33 + lactobacillus acidophilus LA 14 + bifidobacterium bifidum BGN 4 during 4 months (between 4th and 20th weeks after surgery. 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

Official Title
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Effects of Pre- and Postoperative Probiotics Administration on Postoperative Weight Loss in Patients Undergoing Sleeve Gastrectomy

Conditions
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Weight Loss

Intervention / Treatment
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* Biological: Administration of probiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI >40 BMI >35 associated to diabetes mellitus, hypertension, dyslipidemia or sleep apnea/hypopnea síndrome Patients undergoing laparoscopic sleeve gastrectomy as primary bariatric procedure Exclusion Criteria: Revisional surgery Patients with gastroesophageal reflux disease Patients planned for a sleeve gastrectomy as first step of a second malabsorptive procedure Patients with immune deficiencies or with chronic intake of immune supressor drugs patients refusing to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>Patients will receive the previously mentioned combination of probiotics pre- and postoperatively | Biological: Administration of probiotics<br>* Patients will receive the previously mentioned combination of probiotics before and after surgery<br>|
| No Intervention: No probiotics<br>Patients will not receive probiotics | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |