Pre- and Postoperative Probiotics Administration in Patients Undergoing Sleeve Gastrectomy

Last updated: April 26, 2020
Sponsor: Hospital General Universitario Elche
Overall Status: Active - Not Recruiting

Phase

3

Condition

Weight Loss

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT04367428
Garcilaso-Mex 2020/4
  • Ages 18-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • BMI >40

  • BMI >35 associated to diabetes mellitus, hypertension, dyslipidemia or sleepapnea/hypopnea síndrome

  • Patients undergoing laparoscopic sleeve gastrectomy as primary bariatric procedure

Exclusion

Exclusion Criteria:

  • Revisional surgery

  • Patients with gastroesophageal reflux disease

  • Patients planned for a sleeve gastrectomy as first step of a second malabsorptiveprocedure

  • Patients with immune deficiencies or with chronic intake of immune supressor drugs

  • patients refusing to participate in the study

Study Design

Total Participants: 60
Study Start date:
May 02, 2020
Estimated Completion Date:
July 31, 2021

Study 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