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Pre- and Postoperative Probiotics Administration in Patients Undergoing Sleeve Gastrectomy

Primary Purpose

Weight Loss

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Administration of probiotics
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Probiotics

    No probiotics

    Arm Description

    Patients will receive the previously mentioned combination of probiotics pre- and postoperatively

    Patients will not receive probiotics

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    Remission of diabetes mellitus
    Remission of diabetes mellitus will be defined as fasting glucose <100mg/dl and glycated hemoglobin <6% at blood sample
    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

    Full Information

    First Posted
    April 26, 2020
    Last Updated
    April 26, 2020
    Sponsor
    Hospital General Universitario Elche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04367428
    Brief Title
    Pre- and Postoperative Probiotics Administration in Patients Undergoing Sleeve Gastrectomy
    Official Title
    Effects of Pre- and Postoperative Probiotics Administration on Postoperative Weight Loss in Patients Undergoing Sleeve Gastrectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2, 2020 (Anticipated)
    Primary Completion Date
    July 31, 2021 (Anticipated)
    Study Completion Date
    July 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital General Universitario Elche

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotics
    Arm Type
    Experimental
    Arm Description
    Patients will receive the previously mentioned combination of probiotics pre- and postoperatively
    Arm Title
    No probiotics
    Arm Type
    No Intervention
    Arm Description
    Patients will not receive probiotics
    Intervention Type
    Biological
    Intervention Name(s)
    Administration of probiotics
    Intervention Description
    Patients will receive the previously mentioned combination of probiotics before and after surgery
    Primary Outcome Measure Information:
    Title
    Weight loss
    Description
    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)
    Time Frame
    1 year after surgery
    Secondary Outcome Measure Information:
    Title
    Remission of diabetes mellitus
    Description
    Remission of diabetes mellitus will be defined as fasting glucose <100mg/dl and glycated hemoglobin <6% at blood sample
    Time Frame
    1 year after surgery
    Title
    Remission of dyslipidemia
    Description
    Remission of dyslipidemia will be defined as triglycerids <200mg/dl, total cholesterol<200mg/dl and HDL-colesterol >45mg/dl at blood sample
    Time Frame
    1 year after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jaime Ruiz-Tovar
    Phone
    +34630534808
    Email
    jruiztovar@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carolina Llavero
    Phone
    +37649593020
    Email
    carolinallavero@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gilberto Gonzalez
    Organizational Affiliation
    Hospital Angeles del Carmen, Guadalajara, Mexico
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Pre- and Postoperative Probiotics Administration in Patients Undergoing Sleeve Gastrectomy

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