Pre- and Postoperative Probiotics Administration in Patients Undergoing Sleeve Gastrectomy

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

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

Study Overview

• Status: Unknown
• Conditions: Weight Loss
• Intervention / Treatment: Biological: Administration of probiotics

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jaime Ruiz-Tovar; Phone Number: +34630534808; Email: jruiztovar@gmail.com
• Study Contact Backup: Name: Carolina Llavero; Phone Number: +37649593020; Email: carolinallavero@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital General Universitario Elche
• Investigators: Study Director: Gilberto Gonzalez, Hospital Angeles del Carmen, Guadalajara, Mexico

Study record dates

Study Major Dates

• Study Start (Anticipated): May 2, 2020
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): July 31, 2021

Study Registration Dates

• First Submitted: April 26, 2020
• First Submitted That Met QC Criteria: April 26, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 26, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: Garcilaso-Mex 2020/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No