Bariatric Surgery Candidate Clinical Trial
Official title:
The Effect of Probiotic Supplementation on Systemic Inflammation and Metabolic Endotoxemia in Morbidly Obese Patients Undergoing Bariatric Surgery
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Poland | Medical University of Gdansk | Gdansk | Pomeranian |
Lead Sponsor | Collaborator |
---|---|
Medical University of Gdansk | Pomeranian Medical University Szczecin |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of changes in weight loss of the body | Weight loss will be measured and expressed in kilograms | 3 and 6 months after surgery | |
Primary | 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 | Evaluation of changes in the state of the intestinal microbiota - the content of intestinal microbiota | 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 | |
Secondary | Evaluation of changes in the state of the intestinal microbiota - the content of bacterial metabolites short-chain fatty acids (SCFA) | 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 | |
Secondary | Evaluation of changes in the permeability of the intestinal barrier | 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 | |
Secondary | Evaluation of changes in the state of the intestinal barrier | 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 | |
Secondary | Evaluation of changes in endotoxemia | Endotoxemia will be assessed by measuring lipopolysaccharide in serum. | before the intervention, 3 and 6 months after surgery | |
Secondary | Evaluation of changes in inflammation profile in serum | The inflammation profile will be assessed by a concentration of cytokines (IL-6, TNF-alfa, IL-10, IL-8, IL-2R) in the serum. | before the intervention, 3 and 6 months after surgery | |
Secondary | Evaluation of changes in intestine inflammation | The intestine inflammation will be measured by the level of calprotectin in the stool | before the intervention, 3 and 6 months after surgery | |
Secondary | Evaluation of changes in nutrition - frequency | The assessment of the nutrition will be performed using the food frequency questionnaire (FFQ) | before the intervention and 6 months after surgery | |
Secondary | Evaluation of changes in nutrition - quality and quantity | The assessment of the nutrition will be performed using a 3-day food record | two weeks before surgery and 3 months after surgery | |
Secondary | Postoperative complications | 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) | During six months after surgery |
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