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

NCT ID: NCT05407090

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-02
• Study Completion Date: 2024-06-30

Brief 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.

Detailed Description

The study is designed as a randomized double-blind placebo-controlled clinical trial with a 12-week probiotics intervention period. Eighty patients qualified for one of 3 types of bariatric surgery Roux-en-Y Gastric Bypass (RYGB), One-Anastomosis Gastric Bypass (OAGB), Laparoscopic Sleeve Gastrectomy (LSG) will be randomized to receive probiotics or a placebo. The time frame for the study is 6 months before and 6 months after surgery.

During this time, it is planned to collect stool samples at 5-time points: before the start of the study, before the introduction of probiotic therapy, 2 weeks before the operation, and 3 and 6 months after the operation. Collected fecal samples will be subjected to quantitative and qualitative content of the intestinal microbiota using the new generation sequencing method, as well as intestinal permeability parameters such as I-FABP (Intestinal fatty acid-binding protein), bacterial short-chain fatty acids (SCFA), and lipopolysaccharide (LPS).

Simultaneously with the collection of stool samples, an assessment of the patient's nutrition will be performed using the food frequency questionnaire (FFQ) and three-day dietary recall.

The blood samples will be collected at 4-time points: before the start of the study, before the operation, and 3 and 6 months after the operation. The following parameters will be marked in the collected blood samples: glucose, insulin, HbA1c, liver tests: ALT (Alanine transaminase), AST (Aspartate transaminase), GGTP (Gamma-glutamyl Transferase), alkaline phosphatase (ALP), bilirubin; lipid profile, CRP (C-reactive protein), total protein, albumin, inflammatory markers: IL-6, IL-10, Tumor necrosis factor-α (TNF-α), IL-8, IL-R2.

During the examination, tissue samples will be taken at 2-time points. The first is during routine gastroscopy before surgery. Gastroscopy will be performed before the inclusion of the probiotic. Duodenal and stomach biopsy will be performed during gastroscopy. The second time tissue samples will be collected intraoperatively. Gastric specimens will be collected from patients undergoing LSG. Patients qualified for RYGB and OAGB surgery will undergo gastric and jejunum biopsy. The parameters of the intestinal barrier status will be assessed in the collected tissues: Plasmalemma Vesicle-Associated Protein-1 (PLVAP-1), and Regenerating Islet Derived Protein 3 Alpha (Reg3α).

Conditions

Bariatric Surgery Candidate; Dysbiosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic

Patients will take 4 capsules of a multi-strain probiotic preparation daily. Product characteristics: 1 capsule of the preparation contains ≥2.5 x 10\^9 CFU / g of live bacteria (Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactococcus lactis W19, Lactococcus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidillum W23)

Group Type: EXPERIMENTAL

probiotic supplementation

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Patients will take 4 capsules of a placebo preparation daily.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

probiotic supplementation

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

Intervention Type: DIETARY_SUPPLEMENT

placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• qualification for LSG, RYGB, OAGB bariatric surgery
• age over 18
• written consent to participate in the study

Exclusion Criteria

• allergy/intolerance to any of the ingredients of the preparations,
• inflammatory bowel diseases,
• current antibiotic therapy,
• immunosuppression,
• biological treatment,
• long-term antibiotic therapy,
• taking probiotics in the 1 month prior to study enrollment,
• neurodegenerative diseases.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pomeranian Medical University Szczecin

OTHER

Sponsor Role: collaborator

Medical University of Gdansk

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marta Potrykus

Role: PRINCIPAL_INVESTIGATOR

Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk

Locations

Medical University of Gdańsk

Gdansk, Pomeranian, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Marta Potrykus

Role: CONTACT

martapotrykus@gumed.edu.pl

512177459

Facility Contacts

Marta Potrykus

Role: primary

martapotrykus@gumed.edu.pl

512177459

References

Potrykus M, Stanislawowski M, Czaja-Stolc S, Potrykus A, Stankiewicz M, Owczarzak A, Guzek M, Szymanski M, Loniewski I, Adrych K, Malgorzewicz S, Kaska L, Slebioda T, Proczko-Stepaniak M. 12-week preoperative probiotic supplementation versus placebo: effects on inflammation, endotoxemia, adipokines, and gastrointestinal peptides in patients six months after bariatric surgery - a double-blind, randomized, placebo-controlled clinical trial. Nutr J. 2025 Oct 9;24(1):156. doi: 10.1186/s12937-025-01217-2.

Reference Type: DERIVED

PMID: 41068905 (View on PubMed)

Other Identifiers

NKBBN/447/2021/MP

Identifier Type: -

Identifier Source: org_study_id