Obesity &Amp; Overweight
Conditions
Keywords
obesity, sleeve gastrectomy, constipation
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
Probiotics containing Bifidobacterium animalis AMT30, Bifidobacterium breve AMT32, and Lactobacillus plantarum AMT14.
OTHERDiet
Placebo
Sponsors
University of Warmia and Mazury in Olsztyn
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age over 18 years. 2. BMI over 40 kg/m² or over 35 kg/m² with obesity-related comorbidities. 3. Successful qualification for sleeve gastrectomy. 4. Informed consent to participate in the study.
Exclusion criteria
1. Age under 18 years. 2. Chronic gastrointestinal diseases. 3. Use of antibiotic therapy within 4 weeks prior to surgery. 4. Lack of consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the impact of probiotics on the resolution of constipation after sleeve gastrectomy | one and three months after surgery | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the impact of probiotics on gastrointestinal symptoms after SG | one and three months after surgery | 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. |
| Metabolic changes after the probiotics use in patients after SG | one and three months after surgery | The secondary aim is to evaluate laboratory tests to identify any metabolic changes associated with probiotic use. It would be: Hemoglobin (Hb): g/dL |
Countries
Poland
Outcome results
None listed