Bariatric Surgery CandidateNCT05407090
The Effect of Probiotics on Systemic Inflammation and Metabolic Endotoxemia in Patients Undergoing Bariatric Surgery
A study testing probiotic supplementation in people with Bariatric Surgery Candidate and Dysbiosis, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
This study explores the effects of probiotic administration on the outcomes of surgical treatment, and also on the state of the intestinal microbiota and the intestinal barrier. The study protocol is designed as a randomized double-blind placebo-controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate, Dysbiosis
- What is being tested?
- probiotic supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 2 Aug 2021to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- qualification for LSG, RYGB, OAGB bariatric surgery
- age over 18
- written consent to participate in the study
Who cannot join
- allergy/intolerance to any of the ingredients of the preparations,
- inflammatory bowel diseases,
- current antibiotic therapy,
- immunosuppression,
- biological treatment,
- long-term antibiotic therapy,
- taking probiotics in the 1 month prior to study enrollment,
- neurodegenerative diseases.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Gdańsk
Gdansk, Pomeranian, 80-210
Marta Potrykus, 512177459, martapotrykus@gumed.edu.pl
About this study
Official title: The Effect of Probiotic Supplementation on Systemic Inflammation and Metabolic Endotoxemia in Morbidly Obese Patients Undergoing Bariatric Surgery
This study explores the effects of probiotic administration on the outcomes of surgical treatment, and also on the state of the intestinal microbiota and the intestinal barrier. The study protocol is designed as a randomized double-blind placebo-controlled clinical trial. Patients qualified for bariatric surgery will be randomized to receive probiotics or a placebo for 12 weeks. Researchers are going to evaluate changes in intestinal microbiota, epithelial permeability, weight loss, postoperative complications, and serum parameters reflecting inflammation, metabolic profile, and metabolic endotoxemia.
Read the detailed description
The study is designed as a randomized double-blind placebo-controlled clinical trial with a 12-week probiotics intervention period. Eighty patients qualified for one of 3 types of bariatric surgery Roux-en-Y Gastric Bypass (RYGB), One-Anastomosis Gastric Bypass (OAGB), Laparoscopic Sleeve Gastrectomy (LSG) will be randomized to receive probiotics or a placebo. The time frame for the study is 6 months before and 6 months after surgery.
During this time, it is planned to collect stool samples at 5-time points: before the start of the study, before the introduction of probiotic therapy, 2 weeks before the operation, and 3 and 6 months after the operation. Collected fecal samples will be subjected to quantitative and qualitative content of the intestinal microbiota using the new generation sequencing method, as well as intestinal permeability parameters such as I-FABP (Intestinal fatty acid-binding protein), bacterial short-chain fatty acids (SCFA), and lipopolysaccharide (LPS).
Simultaneously with the collection of stool samples, an assessment of the patient's nutrition will be performed using the food frequency questionnaire (FFQ) and three-day dietary recall.
The blood samples will be collected at 4-time points: before the start of the study, before the operation, and 3 and 6 months after the operation. The following parameters will be marked in the collected blood samples: glucose, insulin, HbA1c, liver tests: ALT (Alanine transaminase), AST (Aspartate transaminase), GGTP (Gamma-glutamyl Transferase), alkaline phosphatase (ALP), bilirubin; lipid profile, CRP (C-reactive protein), total protein, albumin, inflammatory markers: IL-6, IL-10, Tumor necrosis factor-α (TNF-α), IL-8, IL-R2.
During the examination, tissue samples will be taken at 2-time points. The first is during routine gastroscopy before surgery. Gastroscopy will be performed before the inclusion of the probiotic. Duodenal and stomach biopsy will be performed during gastroscopy. The second time tissue samples will be collected intraoperatively. Gastric specimens will be collected from patients undergoing LSG. Patients qualified for RYGB and OAGB surgery will undergo gastric and jejunum biopsy. The parameters of the intestinal barrier status will be assessed in the collected tissues: Plasmalemma Vesicle-Associated Protein-1 (PLVAP-1), and Regenerating Islet Derived Protein 3 Alpha (Reg3α).
- Conditions
- Bariatric Surgery Candidate, Dysbiosis
- Being tested
- probiotic supplementation, placebo
- Keywords
- microbiota, bariatric surgery, obesity, inflammation, endotoxemia, intestinal permeability
- Medical subject headings
- Dysbiosis, Obesity, Inflammation, Endotoxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic supplementationDietary supplement
Participants enrolled in the probiotic group will receive probiotics for 12 weeks before surgery.
placeboDietary supplement
Participants enrolled in the placebo group will receive a placebo instead of probiotics.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Patients will take 4 capsules of a multi-strain probiotic preparation daily. Product characteristics: 1 capsule of the preparation contains ≥2.5 x 10^9 CFU / g of live bacteria (Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactococcus lactis W19, Lactococcus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidillum W23) Receives: Dietary Supplement: probiotic supplementation |
| Placebo | Placebo comparator | Patients will take 4 capsules of a placebo preparation daily. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of changes in weight loss of the body
Weight loss will be measured and expressed in kilograms
Measured: 3 and 6 months after surgery
Evaluation of changes in inflammation status
The inflammation will be assessed by measuring CRP concentration in the serum
Measured: before the intervention, 3 and 6 months after surgery
Secondary outcomes (10)
Evaluation of changes in the state of the intestinal microbiota - the content of intestinal microbiota
The state of the intestinal microbiota will be measured by quantitative and qualitative content of the intestinal microbiota using the new generation sequencing method (16s rRNA)
Measured: before the intervention, 2 weeks before surgery, 3 and 6 months after surgery
Evaluation of changes in the state of the intestinal microbiota - the content of bacterial metabolites short-chain fatty acids (SCFA)
The state of the intestinal microbiota will be measured by the quantitative and qualitative content of bacterial metabolites - short-chain fatty acids (SCFA)
Measured: before intervention, 2 weeks before surgery, 3 and 6 months after surgery
Evaluation of changes in the permeability of the intestinal barrier
The permeability of the intestinal barrier will be measured by the presence of increased intestinal permeability parameter - I-FABP in stool
Measured: before the intervention, 2 weeks before surgery, 3 and 6 months after surgery
Evaluation of changes in the state of the intestinal barrier
The permeability of the intestinal barrier will be measured by the concentration of PLVAP-1 and Reg3-alfa in collected tissues
Measured: before the intervention, in time of surgery
Evaluation of changes in endotoxemia
Endotoxemia will be assessed by measuring lipopolysaccharide in serum.
Measured: before the intervention, 3 and 6 months after surgery
Evaluation of changes in inflammation profile in serum
The inflammation profile will be assessed by a concentration of cytokines (IL-6, TNF-alfa, IL-10, IL-8, IL-2R) in the serum.
Measured: before the intervention, 3 and 6 months after surgery
Evaluation of changes in intestine inflammation
The intestine inflammation will be measured by the level of calprotectin in the stool
Measured: before the intervention, 3 and 6 months after surgery
Evaluation of changes in nutrition - frequency
The assessment of the nutrition will be performed using the food frequency questionnaire (FFQ)
Measured: before the intervention and 6 months after surgery
Evaluation of changes in nutrition - quality and quantity
The assessment of the nutrition will be performed using a 3-day food record
Measured: two weeks before surgery and 3 months after surgery
Postoperative complications
Postoperative complications will be assessed by the Clavien-Dindo classification of surgical complications (on a scale of 1 to 5, the higher the result, the more intensive treatment is required for the described complication)
Measured: During six 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 posted7 Jun 2022
- Study start2 Aug 2021
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Collaborators
- Pomeranian Medical University Szczecin
- Responsible party
- Sponsor
- Investigators
- Marta Potrykus, Principal investigator, Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407090
- Sponsor's protocol ID
- NKBBN/447/2021/MP
- Status last verified
- Jun 2022
- First submitted
- 25 May 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Potrykus M, Stanislawowski M, Czaja-Stolc S, Potrykus A, Stankiewicz M, Owczarzak A, Guzek M, Szymanski M, Loniewski I, Adrych K, Malgorzewicz S, Kaska L, Slebioda T, Proczko-Stepaniak M. 12-week preoperative probiotic supplementation versus placebo: effects on inflammation, endotoxemia, adipokines, and gastrointestinal peptides in patients six months after bariatric surgery - a double-blind, randomized, placebo-controlled clinical trial. Nutr J. 2025 Oct 9;24(1):156. doi: 10.1186/s12937-025-01217-2.
PubMed 41068905
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotic Supplementation on Systemic Inflammation and Metabolic Endotoxemia in Morbidly Obese Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05407090
- Acronym / sponsor ID
- NKBBN/447/2021/MP
- Conditions
- Bariatric Surgery Candidate, Dysbiosis
- Keywords
- microbiota, bariatric surgery, obesity, inflammation, endotoxemia, intestinal permeability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Collaborators
- Pomeranian Medical University Szczecin
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 7 Jun 2022 (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.
This study explores the effects of probiotic administration on the outcomes of surgical treatment, and also on the state of the intestinal microbiota and the intestinal barrier. The study protocol is designed as a randomized double-blind placebo-controlled clinical trial. Patients qualified for bariatric surgery will be randomized to receive probiotics or a placebo for 12 weeks. Researchers are going to evaluate changes in intestinal microbiota, epithelial permeability, weight loss, postoperative complications, and serum parameters reflecting inflammation, metabolic profile, and metabolic endotoxemia.
Detailed description
The study is designed as a randomized double-blind placebo-controlled clinical trial with a 12-week probiotics intervention period. Eighty patients qualified for one of 3 types of bariatric surgery Roux-en-Y Gastric Bypass (RYGB), One-Anastomosis Gastric Bypass (OAGB), Laparoscopic Sleeve Gastrectomy (LSG) will be randomized to receive probiotics or a placebo. The time frame for the study is 6 months before and 6 months after surgery.
During this time, it is planned to collect stool samples at 5-time points: before the start of the study, before the introduction of probiotic therapy, 2 weeks before the operation, and 3 and 6 months after the operation. Collected fecal samples will be subjected to quantitative and qualitative content of the intestinal microbiota using the new generation sequencing method, as well as intestinal permeability parameters such as I-FABP (Intestinal fatty acid-binding protein), bacterial short-chain fatty acids (SCFA), and lipopolysaccharide (LPS).
Simultaneously with the collection of stool samples, an assessment of the patient's nutrition will be performed using the food frequency questionnaire (FFQ) and three-day dietary recall.
The blood samples will be collected at 4-time points: before the start of the study, before the operation, and 3 and 6 months after the operation. The following parameters will be marked in the collected blood samples: glucose, insulin, HbA1c, liver tests: ALT (Alanine transaminase), AST (Aspartate transaminase), GGTP (Gamma-glutamyl Transferase), alkaline phosphatase (ALP), bilirubin; lipid profile, CRP (C-reactive protein), total protein, albumin, inflammatory markers: IL-6, IL-10, Tumor necrosis factor-α (TNF-α), IL-8, IL-R2.
During the examination, tissue samples will be taken at 2-time points. The first is during routine gastroscopy before surgery. Gastroscopy will be performed before the inclusion of the probiotic. Duodenal and stomach biopsy will be performed during gastroscopy. The second time tissue samples will be collected intraoperatively. Gastric specimens will be collected from patients undergoing LSG. Patients qualified for RYGB and OAGB surgery will undergo gastric and jejunum biopsy. The parameters of the intestinal barrier status will be assessed in the collected tissues: Plasmalemma Vesicle-Associated Protein-1 (PLVAP-1), and Regenerating Islet Derived Protein 3 Alpha (Reg3α).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: probiotic supplementationPatients will take 4 capsules of a multi-strain probiotic preparation daily. Product characteristics: 1 capsule of the preparation contains ≥2.5 x 10^9 CFU / g of live bacteria (Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactococcus lactis W19, Lactococcus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidillum W23) |
| Placebo | Placebo comparator | Dietary Supplement: placeboPatients will take 4 capsules of a placebo preparation daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- qualification for LSG, RYGB, OAGB bariatric surgery
- age over 18
- written consent to participate in the study
Key exclusion criteria (8 listed)
- allergy/intolerance to any of the ingredients of the preparations,
- inflammatory bowel diseases,
- current antibiotic therapy,
- immunosuppression,
- biological treatment,
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 |
|---|---|---|
| probiotic supplementationParticipants enrolled in the probiotic group will receive probiotics for 12 weeks before surgery. | Dietary supplement | Probiotic |
| placeboParticipants enrolled in the placebo group will receive a placebo instead of probiotics. | Dietary supplement | Placebo |
Primary outcome
Evaluation of changes in weight loss of the body
Time frame: 3 and 6 months after surgery
Weight loss will be measured and expressed in kilograms
Evaluation of changes in inflammation status
Time frame: before the intervention, 3 and 6 months after surgery
The inflammation will be assessed by measuring CRP concentration in the serum
10 secondary outcomes
Evaluation of changes in the state of the intestinal microbiota - the content of intestinal microbiota
Time frame: before the intervention, 2 weeks before surgery, 3 and 6 months after surgery
Evaluation of changes in the state of the intestinal microbiota - the content of bacterial metabolites short-chain fatty acids (SCFA)
Time frame: before intervention, 2 weeks before surgery, 3 and 6 months after surgery
Evaluation of changes in the permeability of the intestinal barrier
Time frame: before the intervention, 2 weeks before surgery, 3 and 6 months after surgery
Evaluation of changes in the state of the intestinal barrier
Time frame: before the intervention, in time of surgery
Evaluation of changes in endotoxemia
Time frame: before the intervention, 3 and 6 months after surgery
Evaluation of changes in inflammation profile in serum
Time frame: before the intervention, 3 and 6 months after surgery
Evaluation of changes in intestine inflammation
Time frame: before the intervention, 3 and 6 months after surgery
Evaluation of changes in nutrition - frequency
Time frame: before the intervention and 6 months after surgery
Evaluation of changes in nutrition - quality and quantity
Time frame: two weeks before surgery and 3 months after surgery
Postoperative complications
Time frame: During six months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Derived from this study: PubMed 41068905Potrykus M, Stanislawowski M, Czaja-Stolc S, Potrykus A, Stankiewicz M, Owczarzak A, Guzek M, Szymanski M, Loniewski I, Adrych K, Malgorzewicz S, Kaska L, Slebioda T, Proczko-Stepaniak M. 12-week preoperative probiotic supplementation versus placebo: effects on inflammation, endotoxemia, adipokines, and gastrointestinal peptides in patients six months after bariatric surgery - a double-blind, randomized, placebo-controlled clinical trial. Nutr J. 2025 Oct 9;24(1):156. doi: 10.1186/s12937-025-01217-2.
- 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.
Marta Potrykus principal investigator
Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk
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 supplementation in people with Bariatric Surgery Candidate and Dysbiosis, run by Medical University of Gdansk 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Potrykus (512177459, martapotrykus@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of changes in weight loss of the body (time frame: 3 and 6 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05407090, which also lists 1 linked publication.
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 7 Jun 2022.