The planned study aims to assess whether probiotics improve the quality of life in patients during the early postoperative period following sleeve gastrectomy, and whether they influence the absorption of micro- and macronutrients. Patients eligible for inclusion will have a BMI of 40 kg/m² or higher and must have successfully completed the qualification process for sleeve gastrectomy. Exclusion criteria include chronic gastrointestinal diseases, antibiotic use within 4 weeks prior to surgery, and lack of consent to participate in the study. On the day before surgery, a stool sample will be collected from each patient for microbiological analysis to assess the composition of gut bacteria. Patients will then undergo sleeve gastrectomy using a standard surgical technique. After the operation, participants will be randomized into two groups. The first group will receive probiotics containing Bifidobacterium animalis AMT30, Bifidobacterium breve AMT32, and Lactobacillus plantarum AMT14. These strains are deposited in the Polish Collection of Microorganisms at the Polish Academy of Sciences in Wrocław and are protected by Polish, European, and U.S. patents. The second group will receive a placebo. As part of follow-up, stool samples will be collected again one month and three months after surgery for comparative microbiological analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
University of Warmia and Mazury
Olsztyn, Poland
Assessment of the impact of probiotics on the resolution of constipation after sleeve gastrectomy
The primary outcome of the study is to assess the effect of probiotics on the frequency of defecation in the early weeks following surgery. The patient would be asked whether constipation occurred (yes or no).
Time frame: one and three months after surgery
Assessment of the impact of probiotics on gastrointestinal symptoms after SG
The secondary outcome of the study is to assess the effect of probiotics on the frequency of defecation in the early weeks following surgery. The patient would be asked about the number of stools passing per week.
Time frame: one and three months after surgery
Assessment of the impact of probiotics on gastrointestinal symptoms after SG
The secondary outcome of the study is to assess the effect of probiotics on the frequency of defecation in the early weeks following surgery. The patient would be asked about the subjective assessment of the ease of defecation. A Likert scale of 1-5 was used, where 1 indicated great difficulty with defecation, and 5 indicated no difficulty with defecation.
Time frame: one and three months after surgery
Assessment of the impact of probiotics on gastrointestinal symptoms after SG
The secondary outcome of the study is to assess the effect of probiotics on the frequency of defecation in the early weeks following surgery. The patient would be asked about the feeling of bowel movement completeness. A Likert scale of 1-5 was used, where 1 indicated a complete feeling of incomplete defecation, and 5 indicated a complete feeling of defecation.
Time frame: one and three months after surgery
Metabolic changes after the probiotics use in patients after SG
The secondary aim is to evaluate laboratory tests to identify any metabolic changes associated with probiotic use. It would be: Hemoglobin (Hb): g/dL
Time frame: one and three months after surgery
Metabolic changes after the probiotics use in patients after SG
The secondary aim is to evaluate laboratory tests to identify any metabolic changes associated with probiotic use. It would be: Creatinine: mg/dL
Time frame: one and three months after surgery
Metabolic changes after the probiotics use in patients after SG
The secondary aim is to evaluate laboratory tests to identify any metabolic changes associated with probiotic use. It would be: Total Protein: g/L
Time frame: one and three months after surgery
Metabolic changes after the probiotics use in patients after SG
The secondary aim is to evaluate laboratory tests to identify any metabolic changes associated with probiotic use. It would be: Total Cholesterol: mg/dL
Time frame: one and three months after surgery
Metabolic changes after the probiotics use in patients after SG
The secondary aim is to evaluate laboratory tests to identify any metabolic changes associated with probiotic use. It would be: HbA1c: %
Time frame: one and three months after surgery
Metabolic changes after the probiotics use in patients after SG
The secondary aim is to evaluate laboratory tests to identify any metabolic changes associated with probiotic use. It would be: Ferritin: µg/L (ng/mL)
Time frame: one and three months after surgery
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