Pre- and Postoperative Probiotics Administration in Patients Undergoing Sleeve Gastrectomy
NCT ID: NCT04367428
Last Updated: 2020-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2020-05-02
2021-07-31
Brief Summary
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* 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
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Probiotics
Patients will receive the previously mentioned combination of probiotics pre- and postoperatively
Administration of probiotics
Patients will receive the previously mentioned combination of probiotics before and after surgery
No probiotics
Patients will not receive probiotics
No interventions assigned to this group
Interventions
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Administration of probiotics
Patients will receive the previously mentioned combination of probiotics before and after surgery
Eligibility Criteria
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Inclusion Criteria
* BMI \>35 associated to diabetes mellitus, hypertension, dyslipidemia or sleep apnea/hypopnea síndrome
* Patients undergoing laparoscopic sleeve gastrectomy as primary bariatric procedure
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hospital General Universitario Elche
OTHER
Responsible Party
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Jaime Ruiz-Tovar, MD, PhD
Head of Bariatric Surgery Unit
Principal Investigators
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Gilberto Gonzalez
Role: STUDY_DIRECTOR
Hospital Angeles del Carmen, Guadalajara, Mexico
Central Contacts
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Other Identifiers
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Garcilaso-Mex 2020/4
Identifier Type: -
Identifier Source: org_study_id
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