The Impact of Probiotics on Bariatric Treatment Outcomes
NCT ID: NCT07258732
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-07-10
2026-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
Diet
Placebo
Control
Probiotic
Probiotics containing Bifidobacterium animalis AMT30, Bifidobacterium breve AMT32, and Lactobacillus plantarum AMT14.
Interventions
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Probiotic
Probiotics containing Bifidobacterium animalis AMT30, Bifidobacterium breve AMT32, and Lactobacillus plantarum AMT14.
Diet
Placebo
Eligibility Criteria
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Inclusion Criteria
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
2. Chronic gastrointestinal diseases.
3. Use of antibiotic therapy within 4 weeks prior to surgery.
4. Lack of consent to participate in the study.
18 Years
ALL
No
Sponsors
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University of Warmia and Mazury in Olsztyn
OTHER
Responsible Party
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Natalia Dowgiałło-Gornowicz, MD, PhD
Associate Professor
Locations
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University of Warmia and Mazury
Olsztyn, , Poland
Countries
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Other Identifiers
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1/2024
Identifier Type: -
Identifier Source: org_study_id
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