NCT04367428

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2020

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

May 2, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

1.2 years

First QC Date

April 26, 2020

Last Update Submit

April 26, 2020

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Remission of diabetes mellitus

    1 year after surgery

  • Remission of dyslipidemia

    1 year after surgery

Study Arms (2)

Probiotics

EXPERIMENTAL

Patients will receive the previously mentioned combination of probiotics pre- and postoperatively

Biological: Administration of probiotics

No probiotics

NO INTERVENTION

Patients will not receive probiotics

Interventions

Administration of probioticsBIOLOGICAL

Patients will receive the previously mentioned combination of probiotics before and after surgery

Probiotics

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>40
  • BMI \>35 associated to diabetes mellitus, hypertension, dyslipidemia or sleep apnea/hypopnea síndrome
  • Patients undergoing laparoscopic sleeve gastrectomy as primary bariatric procedure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gilberto Gonzalez

    Hospital Angeles del Carmen, Guadalajara, Mexico

    STUDY DIRECTOR

Central Study Contacts

Jaime Ruiz-Tovar

CONTACT

+34630534808jruiztovar@gmail.com

Carolina Llavero

CONTACT

+37649593020carolinallavero@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Bariatric Surgery Unit

Study Record Dates

First Submitted

April 26, 2020

First Posted

April 29, 2020

Study Start

May 2, 2020

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

April 29, 2020

Record last verified: 2020-04