An interventional study of probiotic supplementation and placebo in Bariatric Surgery Candidate and Dysbiosis, sponsored by Medical University of Gdansk. Status unknown at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-07.
Sponsored by Medical University of Gdansk · Not applicable, Interventional, and Supportive care
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.
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).
187 studies on the registry are indexed under Dysbiosis; 64 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 132 interventional studies indexed under Dysbiosis.
Browse Dysbiosis studies →Medical University of Gdansk is the lead sponsor of 133 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Patients will take 4 capsules of a placebo preparation daily.
Dietary Supplement: placebo
Participants enrolled in the probiotic group will receive probiotics for 12 weeks before surgery.
Participants enrolled in the placebo group will receive a placebo instead of probiotics.
Evaluation of changes in weight loss of the body
Weight loss will be measured and expressed in kilograms
Time frame: 3 and 6 months after surgery
Evaluation of changes in inflammation status
The inflammation will be assessed by measuring CRP concentration in the serum
Time frame: before the intervention, 3 and 6 months after surgery
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)
Time frame: 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)
The state of the intestinal microbiota will be measured by the quantitative and qualitative content of bacterial metabolites - short-chain fatty acids (SCFA)
Time frame: before intervention, 2 weeks before surgery, 3 and 6 months after surgery
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
Time frame: before the intervention, 2 weeks before surgery, 3 and 6 months after surgery
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
Time frame: before the intervention, in time of surgery
Evaluation of changes in endotoxemia
Endotoxemia will be assessed by measuring lipopolysaccharide in serum.
Time frame: before the intervention, 3 and 6 months after surgery
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.
Time frame: before the intervention, 3 and 6 months after surgery
Evaluation of changes in intestine inflammation
The intestine inflammation will be measured by the level of calprotectin in the stool
Time frame: before the intervention, 3 and 6 months after surgery
Evaluation of changes in nutrition - frequency
The assessment of the nutrition will be performed using the food frequency questionnaire (FFQ)
Time frame: before the intervention and 6 months after surgery
Evaluation of changes in nutrition - quality and quantity
The assessment of the nutrition will be performed using a 3-day food record
Time frame: two weeks before surgery and 3 months after surgery
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)
Time frame: During six months after surgery
Plan to share: No
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This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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