Pre- and Postoperative Probiotics Administration in Patients Undergoing Sleeve Gastrectomy

Phase 3

• Conditions: Weight Loss
• Interventions: Biological: Administration of probiotics

• Registration Number: NCT04367428
• Lead Sponsor: Hospital General Universitario Elche

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

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-26
• Study First Submitted QC: 2020-04-26
• Last Update Submitted: 2020-04-26
• Study First Posted: 2020-04-29
• Last Update Posted: 2020-04-29
• Study Start: 2020-05-02
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	Administration of probiotics	Patients will receive the previously mentioned combination of probiotics pre- and postoperatively

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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