Clinical trial NCT04367428: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Weight Loss
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Weight loss
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Remission of diabetes mellitus
timeFrame: 1 year after surgery
measure: Remission of dyslipidemia
timeFrame: 1 year after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Angeles del Carmen, Guadalajara, Mexico
name: Gilberto Gonzalez
role: STUDY_DIRECTOR
References: