Obesity &Amp; OverweightPROBENCT07258732
The Impact of Probiotics on Bariatric Treatment Outcomes
A study testing Probiotic and Diet in people with Obesity &Amp; Overweight, run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity &Amp; Overweight
- What is being tested?
- Probiotic and Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 10 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age under 18 years.
- Chronic gastrointestinal diseases.
- Use of antibiotic therapy within 4 weeks prior to surgery.
- Lack of consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Impact of Probiotics on Postoperative Gastrointestinal Symptoms and Gut Microbiota After Sleeve Gastrectomy: A Randomized-Control Trial
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.
Read more
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.
- Conditions
- Obesity &Amp; Overweight
- Being tested
- Probiotic, Diet
- Keywords
- obesity, sleeve gastrectomy, constipation
- Medical subject headings
- Obesity, Overweight, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Probiotics containing Bifidobacterium animalis AMT30, Bifidobacterium breve AMT32, and Lactobacillus plantarum AMT14.
DietOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Diet |
| Control | Active comparator | Not described Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one and three months after surgery
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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: %
Measured: 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)
Measured: one and three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start10 Jul 2025
- Primary completion10 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity &Amp; OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Warmia and Mazury in Olsztyn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalia Dowgiałło-Gornowicz, MD, PhD, University of Warmia and Mazury in Olsztyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258732
- Sponsor's protocol ID
- 1/2024
- Acronym
- PROBE
- Status last verified
- Nov 2025
- First submitted
- 10 Jul 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Impact of Probiotics on Postoperative Gastrointestinal Symptoms and Gut Microbiota After Sleeve Gastrectomy: A Randomized-Control Trial
- ClinicalTrials.gov ID
- NCT07258732
- Acronym / sponsor ID
- PROBE / 1/2024
- Conditions
- Obesity &Amp; Overweight
- Keywords
- obesity, sleeve gastrectomy, constipation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Warmia and Mazury in OlsztynUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Diet |
| Control | Active comparator | Dietary Supplement: Probiotic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Age under 18 years.
- Chronic gastrointestinal diseases.
- Use of antibiotic therapy within 4 weeks prior to surgery.
- Lack of consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticProbiotics containing Bifidobacterium animalis AMT30, Bifidobacterium breve AMT32, and Lactobacillus plantarum AMT14. | Dietary supplement | Control |
| DietPlacebo | Other | Placebo |
Primary outcome
Assessment of the impact of probiotics on the resolution of constipation after sleeve gastrectomy
Time frame: 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).
9 secondary outcomes
Assessment of the impact of probiotics on gastrointestinal symptoms after SG
Time frame: one and three months after surgery
Assessment of the impact of probiotics on gastrointestinal symptoms after SG
Time frame: one and three months after surgery
Assessment of the impact of probiotics on gastrointestinal symptoms after SG
Time frame: one and three months after surgery
Metabolic changes after the probiotics use in patients after SG
Time frame: one and three months after surgery
Metabolic changes after the probiotics use in patients after SG
Time frame: one and three months after surgery
Metabolic changes after the probiotics use in patients after SG
Time frame: one and three months after surgery
Metabolic changes after the probiotics use in patients after SG
Time frame: one and three months after surgery
Metabolic changes after the probiotics use in patients after SG
Time frame: one and three months after surgery
Metabolic changes after the probiotics use in patients after SG
Time frame: one and three months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic and Diet in people with Obesity &Amp; Overweight, run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the impact of probiotics on the resolution of constipation after sleeve gastrectomy (time frame: one and three months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.