Pre- and Postoperative Probiotics Administration in Patients Undergoing Sleeve Gastrectomy

Hospital General Universitario Elche

Status and phase

Unknown

Phase 3

Conditions

Weight Loss

Treatments

Biological: Administration of probiotics

Study type

Interventional

Funder types

Other

Identifiers

NCT04367428

Garcilaso-Mex 2020/4

Details and patient eligibility

About

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

Full 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

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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