Weight Loss
Conditions
Brief summary
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
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
Interventions
BIOLOGICALAdministration of probiotics
Patients will receive the previously mentioned combination of probiotics before and after surgery
Sponsors
Hospital General Universitario Elche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | 1 year after surgery | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remission of diabetes mellitus | 1 year after surgery | Remission of diabetes mellitus will be defined as fasting glucose \<100mg/dl and glycated hemoglobin \<6% at blood sample |
| Remission of dyslipidemia | 1 year after surgery | Remission of dyslipidemia will be defined as triglycerids \<200mg/dl, total cholesterol\<200mg/dl and HDL-colesterol \>45mg/dl at blood sample |
Contacts
Primary ContactJaime Ruiz-Tovar
Backup ContactCarolina Llavero
Outcome results
None listed