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

NCT05407090 | Unknown

• 1 other identifier: NKBBN/447/2021/MP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; Dysbiosis

Keywords

microbiota; bariatric surgery; obesity; inflammation; endotoxemia; intestinal permeability

Outcome Measures

Primary Outcomes (2)

• Evaluation of changes in weight loss of the body

  Weight loss will be measured and expressed in kilograms

  3 and 6 months after surgery

• Evaluation of changes in inflammation status

  The inflammation will be assessed by measuring CRP concentration in the serum

  before the intervention, 3 and 6 months after surgery

Secondary Outcomes (10)

• Evaluation of changes in the state of the intestinal microbiota - the content of intestinal microbiota

  before the intervention, 2 weeks before surgery, 3 and 6 months after surgery

• Evaluation of changes in the state of the intestinal microbiota - the content of bacterial metabolites short-chain fatty acids (SCFA)

  before intervention, 2 weeks before surgery, 3 and 6 months after surgery

• Evaluation of changes in the permeability of the intestinal barrier

  before the intervention, 2 weeks before surgery, 3 and 6 months after surgery

• Evaluation of changes in the state of the intestinal barrier

  before the intervention, in time of surgery

• Evaluation of changes in endotoxemia

  before the intervention, 3 and 6 months after surgery

Study Arms (2)

Probiotic

EXPERIMENTAL

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)

Dietary Supplement: probiotic supplementation

Placebo

PLACEBO COMPARATOR

Patients will take 4 capsules of a placebo preparation daily.

Dietary Supplement: placebo

Interventions

probiotic supplementation DIETARY_SUPPLEMENT

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

Probiotic

placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Gdansk: lead
• Pomeranian Medical University Szczecin: collaborator

Study Sites (1)

Medical University of Gdańsk

Gdansk, Pomeranian, 80-210, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 41068905 DERIVED

MeSH Terms

Conditions

Dysbiosis; Obesity; Inflammation; Endotoxemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome

Study Officials

• Marta Potrykus

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Potrykus

CONTACT

512177459; martapotrykus@gumed.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 7, 2022
• Study Start: August 2, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)