Pre- & Postoperative Probiotics Administration in Patients Undergoing

Status Not yet recruiting

Clinical Trial Summary

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Weight Loss

Clinical Trial Details

NCT number	NCT04367428
Study type	Interventional
Source	Hospital General Universitario Elche
Contact	Jaime Ruiz-Tovar
Phone	+34630534808
Email	jruiztovar@gmail.com
Status	Not yet recruiting
Phase	Phase 3
Start date	May 2, 2020
Completion date	July 31, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pre- and Postoperative Probiotics Administration in Patients Undergoing Sleeve Gastrectomy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms