- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05407090
The Effect of Probiotics on Systemic Inflammation and Metabolic Endotoxemia in Patients Undergoing Bariatric Surgery
The Effect of Probiotic Supplementation on Systemic Inflammation and Metabolic Endotoxemia in Morbidly Obese Patients Undergoing Bariatric Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marta Potrykus
- Phone Number: 512177459
- Email: martapotrykus@gumed.edu.pl
Study Locations
-
-
Pomeranian
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Gdańsk, Pomeranian, Poland, 80-210
- Recruiting
- Medical University of Gdansk
-
Contact:
- Marta Potrykus
- Phone Number: 512177459
- Email: martapotrykus@gumed.edu.pl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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)
|
Participants enrolled in the probiotic group will receive probiotics for 12 weeks before surgery.
|
Placebo Comparator: Placebo
Patients will take 4 capsules of a placebo preparation daily.
|
Participants enrolled in the placebo group will receive a placebo instead of probiotics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of changes in weight loss of the body
Time Frame: 3 and 6 months after surgery
|
Weight loss will be measured and expressed in kilograms
|
3 and 6 months after surgery
|
Evaluation of changes in inflammation status
Time Frame: before the intervention, 3 and 6 months after surgery
|
The inflammation will be assessed by measuring CRP concentration in the serum
|
before the intervention, 3 and 6 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of changes in the state of the intestinal microbiota - the content of intestinal microbiota
Time Frame: before the intervention, 2 weeks before surgery, 3 and 6 months after surgery
|
The state of the intestinal microbiota will be measured by quantitative and qualitative content of the intestinal microbiota using the new generation sequencing method (16s rRNA)
|
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)
Time Frame: before intervention, 2 weeks before surgery, 3 and 6 months after surgery
|
The state of the intestinal microbiota will be measured by the quantitative and qualitative 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
Time Frame: before the intervention, 2 weeks before surgery, 3 and 6 months after surgery
|
The permeability of the intestinal barrier will be measured by the presence of increased intestinal permeability parameter - I-FABP in stool
|
before the intervention, 2 weeks before surgery, 3 and 6 months after surgery
|
Evaluation of changes in the state of the intestinal barrier
Time Frame: before the intervention, in time of surgery
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The permeability of the intestinal barrier will be measured by the concentration of PLVAP-1 and Reg3-alfa in collected tissues
|
before the intervention, in time of surgery
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Evaluation of changes in endotoxemia
Time Frame: before the intervention, 3 and 6 months after surgery
|
Endotoxemia will be assessed by measuring lipopolysaccharide in serum.
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before the intervention, 3 and 6 months after surgery
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Evaluation of changes in inflammation profile in serum
Time Frame: before the intervention, 3 and 6 months after surgery
|
The inflammation profile will be assessed by a concentration of cytokines (IL-6, TNF-alfa, IL-10, IL-8, IL-2R) in the serum.
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before the intervention, 3 and 6 months after surgery
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Evaluation of changes in intestine inflammation
Time Frame: before the intervention, 3 and 6 months after surgery
|
The intestine inflammation will be measured by the level of calprotectin in the stool
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before the intervention, 3 and 6 months after surgery
|
Evaluation of changes in nutrition - frequency
Time Frame: before the intervention and 6 months after surgery
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The assessment of the nutrition will be performed using the food frequency questionnaire (FFQ)
|
before the intervention and 6 months after surgery
|
Evaluation of changes in nutrition - quality and quantity
Time Frame: two weeks before surgery and 3 months after surgery
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The assessment of the nutrition will be performed using a 3-day food record
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two weeks before surgery and 3 months after surgery
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Postoperative complications
Time Frame: During six months after surgery
|
Postoperative complications will be assessed by the Clavien-Dindo classification of surgical complications (on a scale of 1 to 5, the higher the result, the more intensive treatment is required for the described complication)
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During six months after surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marta Potrykus, Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NKBBN/447/2021/MP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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