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Status unknownNCT04367428Updated Apr 29, 2020

Pre- and Postoperative Probiotics Administration in Patients Undergoing Sleeve Gastrectomy

A Phase 3 interventional study of Administration of probiotics in Weight Loss, sponsored by Hospital General Universitario Elche. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-04-29.

Sponsored by Hospital General Universitario Elche · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the detailed 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

02

Conditions studied

  • Weight Loss

Browse trials for

03

In context

Weight Loss

1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 1,561 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

Hospital General Universitario Elche is the lead sponsor of 44 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • >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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Probiotics

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

    Biological: Administration of probiotics

  • No intervention
    No probiotics

    Patients will not receive probiotics

Interventions

  • BiologicalAdministration of probiotics

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

06

What researchers measure

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)

    Time frame: 1 year after surgery

Secondary outcomes

  1. Remission of diabetes mellitus

    Remission of diabetes mellitus will be defined as fasting glucose \<100mg/dl and glycated hemoglobin \<6% at blood sample

    Time frame: 1 year after surgery

  2. 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

    Time frame: 1 year after surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2020; primary completion for Jul 2021, 14 months later.

Of 23 phase 3 interventional studies under Weight Loss, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 28. This study's planned 14 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 26, 2020
First posted
Apr 29, 2020
StartEst.
May 2, 2020
Primary completionEst.
Jul 31, 2021
CompletionEst.
Jul 31, 2021
Last update
Apr 29, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04367428
Lead sponsor
Hospital General Universitario Elche
Responsible party
Jaime Ruiz-Tovar, MD, PhD (Head of Bariatric Surgery Unit, Hospital General Universitario Elche) — Principal investigator
First posted
Apr 29, 2020
Start date
May 2, 2020 (estimated)
Primary completion
Jul 31, 2021 (estimated)
Completion
Jul 31, 2021 (estimated)
Last update
Apr 29, 2020

Study contacts

Jaime Ruiz-Tovar
Contact
jruiztovar@gmail.com
+34630534808
Carolina Llavero
Contact
carolinallavero@gmail.com
+37649593020
Gilberto Gonzalez
study director · Hospital Angeles del Carmen, Guadalajara, Mexico

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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