NCT07258732Active, not recruiting
The Impact of Probiotics on Bariatric Treatment Outcomes
Study on the Impact of Probiotics on Postoperative Gastrointestinal Symptoms and Gut Microbiota After Sleeve Gastrectomy: A Randomized-Control Trial
Source: ClinicalTrials.gov · Last updated 2 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 10 Jul 2025
- Start date
- 10 Jul 2025
- Primary completion date
- 10 Jul 2026
- Lead sponsor
- University of Warmia and Mazury in Olsztyn
- Diseases
- Obesity
- NCT number
- NCT07258732
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 10 Jul 2025 to the primary completion date, 10 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antibiotic therapy within 4 weeks prior to surgery.
Other illness
- Chronic gastrointestinal diseases.
Age
- Age under 18 years.
Other
- Lack of consent to participate in the study.
Who the study is looking for
- Age over 18 years.
- BMI over 40 kg/m² or over 35 kg/m² with obesity-related comorbidities.
- Successful qualification for sleeve gastrectomy.
- Informed consent to participate in the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Warmia and Mazury Coordinator of this site? Confirm its status | Olsztyn | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.