Pre- and Postoperative Probiotics Administration in Patients Undergoing Sleeve Gastrectomy
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Weight Loss
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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 sc...
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
Tracking Information
- NCT #
- NCT04367428
- Collaborators
- Not Provided
- Investigators
- Study Director: Gilberto Gonzalez Hospital Angeles del Carmen, Guadalajara, Mexico
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