Pre- and Postoperative Probiotics Administration in Patients Undergoing Sleeve Gastrectomy

Weight Loss Clinical Trial

Official title:

Effects of Pre- and Postoperative Probiotics Administration on Postoperative Weight Loss in Patients Undergoing Sleeve Gastrectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04367428
• Other study ID #: Garcilaso-Mex 2020/4
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: April 2020
• Source: Hospital General Universitario Elche
• Contact: Jaime Ruiz-Tovar
• Phone: +34630534808
• Email: jruiztovar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Weight Loss

Intervention

Biological:
• Administration of probiotics
Patients will receive the previously mentioned combination of probiotics before and after surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Weight loss will be assessed as excess body mass index (BMI) loss, calculated by the formula: Excess BMI loss= (preoperative BMI-postoperative BMI)/ (preoperative BMI-25)	1 year after surgery
Secondary	Remission of diabetes mellitus	Remission of diabetes mellitus will be defined as fasting glucose <100mg/dl and glycated hemoglobin <6% at blood sample	1 year after surgery
Secondary	Remission of dyslipidemia	Remission of dyslipidemia will be defined as triglycerids <200mg/dl, total cholesterol<200mg/dl and HDL-colesterol >45mg/dl at blood sample	1 year after surgery