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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Probiotics containing Bifidobacterium animalis AMT30, Bifidobacterium breve AMT32, and Lactobacillus plantarum AMT14. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | one and three months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one and three months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Warmia and Mazury | Olsztyn | 10-015 | Poland |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D004032 | Diet |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Diet | Other | Placebo |
|
| 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. |
| 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. | 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 | 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 | 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 | 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 | 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: % | 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) | one and three months after surgery |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D019602 |
| Food and Beverages |
| D009747 | Nutritional Physiological Phenomena |