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The Effect of Probiotics on Systemic Inflammation and Metabolic Endotoxemia in Patients Undergoing Bariatric Surgery

NCT05407090 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-06-07

No results posted yet for this study

Summary

This study explores the effects of probiotic administration on the outcomes of surgical treatment, and also on the state of the intestinal microbiota and the intestinal barrier. The study protocol is designed as a randomized double-blind placebo-controlled clinical trial. Patients qualified for bariatric surgery will be randomized to receive probiotics or a placebo for 12 weeks. Researchers are going to evaluate changes in intestinal microbiota, epithelial permeability, weight loss, postoperative complications, and serum parameters reflecting inflammation, metabolic profile, and metabolic endotoxemia.

Conditions

Interventions

DIETARY_SUPPLEMENT

probiotic supplementation

Participants enrolled in the probiotic group will receive probiotics for 12 weeks before surgery.

DIETARY_SUPPLEMENT

placebo

Participants enrolled in the placebo group will receive a placebo instead of probiotics.

Sponsors & Collaborators

  • Pomeranian Medical University Szczecin

    collaborator OTHER

  • Medical University of Gdansk

    lead OTHER

Principal Investigators

  • Marta Potrykus · Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-02
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05407090 on ClinicalTrials.gov