Pre- and Postoperative Probiotics Administration in Patients Undergoing Sleeve Gastrectomy

H

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Probiotics
Experimental group
Description:
Patients will receive the previously mentioned combination of probiotics pre- and postoperatively
Treatment:
Biological: Administration of probiotics
No probiotics
No Intervention group
Description:
Patients will not receive probiotics

Trial contacts and locations

0

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Central trial contact

Jaime Ruiz-Tovar; Carolina Llavero

Data sourced from clinicaltrials.gov

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