Insulin ResistanceNCT06092060
The Effect of a Multistrain Probiotic on Metformin Tolerance and Efficacy With Microbiota and Stool Metabolome in Insulin-resistant Women - a 12-week Randomized, Placebo-controlled, Double-blind Study
A study testing the group GS (probiotic) in people with Insulin Resistance, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
The goal of this study is to evaluate the efficacy of metformin on insulin sensitivity and vascular endothelial function with respect to gut microbiota and metabolome in women with established insulin resistance and its tolerance after 12 weeks of probiotic therapy. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- the group GS (probiotic)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2021to 20 Jul 2023
- 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women 25-45 years old, menstruating, BMI 25-32.9 kg / m2, insulin resistance based on the HOMA-IR index (cut-off point 2.5
Who cannot join
- type 1 and 2 diabetes,
- poorly controlled arterial hypertension (mean SBP values> 140mmHg and / or mean DBP values> 90mmHg) within the last month and / or the need to modify pharmacological treatment,
- 2nd degree obesity, BMI> 35 kg / m2,
- lipid disorders requiring pharmacological treatment in the last 3 months before the start of observation or during observation,
- positive history of ischemic heart disease, carotid and / or lower limb atherosclerosis,
- features of heart failure on physical examination and / or additional examinations (chest X-ray, echocardiography),
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- clinically significant arrhythmias or conduction disturbances,
- chronic kidney disease with creatinine clearance <60mL / min / 1.73m2,
- clinically significant impairment of liver function (transaminase values 3 times the normal range),
- acute or chronic, clinically evident inflammatory process (diseases of connective tissue and joints, inflammatory processes of the respiratory tract, inflammatory processes of the genitourinary system, inflammation of the head and neck),
- acute infection in the last month,
- Cancer,
- alcohol abuse, drug addiction,
- taking medications that may interfere with test results,
- Taking antibiotics, steroids, antifungal and antiparasitic agents 4 weeks before the examination (not applicable to topical antifungal agents).
- taking pre - and / or probiotics in the last 12 weeks before the test
- travel to tropical countries in the last 4 weeks prior to the survey
- other conditions that may pose any risk to the patient during the follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Multi-strain Probiotic Consisting of: Bifidobacterium Lactis W52, Lactobacillus Brevis W63, Lactobacillus Casei W56, Lactococcus Lactis W19, Lactococcus Lactis W58, Lactobacillus Acidophilus W37, Bifidobacterium Bifidum W23, Bifidobacterium Lactis W51, and Lactobacillus Salivarius W24 on Metformin Tolerance and Efficacy With Microbiota and Stool Metabolome in Insulin-resistant Women - a 12-week Randomized, Placebo-controlled, Double-blind Study
The goal of this study is to evaluate the efficacy of metformin on insulin sensitivity and vascular endothelial function with respect to gut microbiota and metabolome in women with established insulin resistance and its tolerance after 12 weeks of probiotic therapy.
The hypothesis is probiotic therapy in women with established insulin resistance undergoing metformin treatment increases the drug's efficacy to improve insulin sensitivity and intestinal endothelial function, and reduces gastrointestinal side effects.
Study participants will be randomly assigned to 2 groups, taking a probiotic (GS) or a placebo (GP). The randomization scheme will be computer-generated using permuted blocks of block size 4.
- Conditions
- Insulin Resistance
- Being tested
- the group GS (probiotic), the group GP (placebo)
- Keywords
- Insulin Resistance, Multistrain Probiotic, Gut Microbiota
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the group GS (probiotic)Dietary supplement
The probiotic-supplemented group will receive 2 capsules of freeze-dried powder of a probiotic mixture containing the following bacterial strains twice a day, 3-month: Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactococcus lactis W19, Lactococcus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Lactobacillus salivarius W24
the group GP (placebo)Dietary supplement
The placebo group will receive 2 capsules consisting of the probiotic product carrier, which is corn starch and maltodextrin, twice a day, 3-month.
| Study group | Role | What they receive |
|---|---|---|
| the group GS | Experimental | probiotic treatment group, ca. 20 participants Receives: Dietary Supplement: the group GS (probiotic) |
| the group GP | Placebo comparator | placebo group, ca. 20 participants Receives: Dietary Supplement: the group GP (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative assessment of intestinal microbiota in stool samples
gut bacteria species in stool will be assessed using the shallow shotgun sequencing method, NGS (Next Generation Sequencing)
Measured: up to 10 months
Quantitive change in intestinal microbiota in stool samples
determination of quantitative (Colony forming units - CFU) changes in bacteria in the stool - the shallow shotgun sequencing method, NGS (Next Generation Sequencing) molecular analysis will be used to assess the changes
Measured: up to 10 months
Intestinal metabolome in stool samples
metabolomic analysis (endogenous metabolism (catabolism of amino acids, lipids), biotransformation products under the influence of xenobiotics (e.g., caffeine), fatty acid biosynthesis, fatty acid derivatives, glycolysis, gluconeogenesis, biosynthesis of primary bile acids, amino acid metabolism, sphingolipid metabolism, unknown metabolites, non-targeted metabolome, short-chain fatty acids) will be performed on a quadrupole mass spectrometer coupled with a time-of-flight (QToF) analyzer connected to the AB Sciex - TripleTOF® 6600+ high performance liquid chromatograph (UHPLC)
Measured: up to 10 months
Indicators of insulin sensitivity and carbohydrate metabolism
Analysis of biochemical indicators related to insulin resistance such as concentrations of glucose, insulin, insulin-like growth factor (IGF-1), hemoglobin A1C (HgA1C), myoglobin
Measured: up to 10 months
Evaluation of indicators in stool
Determination of intestinal inflammatory index - fecal calprotectin, determination of intestinal permeability index - fecal zonulin and determination of intestinal membrane inflammatory index sIgA in feces (RT-PCR and Western blotting).
Measured: up to 10 months
Indicators of lipid metabolism
Concentrations of total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, oxidatively modified LDL lipoprotein (oxLDL), paraoxonase (PON) activity, proprotein convertase subtilisin/kexin 9 (PCSK-9)
Measured: up to 10 months
Transcription factors regulating carbohydrate and lipid metabolism
Peroxisome proliferator-activated receptor (PPARγ; NR1C3), PPARγ coactivator, coactivator 1 α ( PGC -1α)
Measured: up to 10 months
Adipokines and myokines
Analysis of biochemical indicators related to insulin resistance such as leptin, adiponectin, resistin, wisfatin, retinol-binding protein type 4 (RBP4), lipocalin-2, proprotein convertase subtilisin/kexin type 9 (PCSK9)
Measured: up to 10 months
Indicators of inflammation
C-reactive protein (hsCRP), interleukin-1 (IL-1), interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor (TNF-alpha), lipocalin-2
Measured: up to 10 months
Indicators of vascular endothelial function
Analysis of biochemical indicators related to insulin resistance and endothelial function, such as endothelial nitric oxide synthase (eNOS), vascular endothelial growth factor (VEGF), homocysteine, plasminogen activator inhibitor 1 (PAI-1), adhesion molecules (sVCAM-1, ICAM-1), monocyte chemoattractant 1(MCP-1), matrix metalloproteinases (MMP-9 and MMP-2), cytosolic fatty acid binding proteins (FABPs)
Measured: up to 10 months
Indicators of a disrupted intestinal barrier in the blood
zonulin, intestinal fatty acid binding protein (I-FABP)
Measured: up to 10 months
Secondary outcomes (4)
Gastrointestinal disorders questionnaire
assessment of gastrointestinal disorders using the Rome IV Questionnaire for adults (selected questions on irritable bowel syndrome, constipation and diarrhea); the statements of the questionnaire relate to frequency and intensity of disorders; higher scores mean worse outcome
Measured: up to 10 months
Body mass analysis (BMI, kg/m^2)
determination of body weight and composition using the electrical bioimpedance method
Measured: up to 10 months
Body composition analysis (percent of total body mass
assessment of bone, fat and fat-free mass using the electrical bioimpedance method
Measured: up to 10 months
Composite measure of Diet composition assessed by food diaries
assessment of protein, fat, carbohydrates, fibre, minerals and vitamins intake using food diaries (grams)
Measured: up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Apr 2021
- Primary completion1 Feb 2022
- Study completion20 Jul 2023
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 Insulin ResistanceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanna Karolkiewicz, Prof, Principal investigator, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092060
- Sponsor's protocol ID
- PoznanUPhyEd Probiotyk
- Status last verified
- Jul 2023
- First submitted
- 6 Apr 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ratajczak M, Bilska A, Musialik K, Skonieczna-Zydecka K, Loniewski I, Gogojewicz A, Karolkiewicz J. Multi-strain probiotic reduces gastrointestinal side effects in women with elevated HOMA-IR index treated with metformin: a 12-week randomised controlled trial. Front Endocrinol (Lausanne). 2026 Mar 3;17:1765741. doi: 10.3389/fendo.2026.1765741. eCollection 2026.
PubMed 41852479
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Multi-strain Probiotic Consisting of: Bifidobacterium Lactis W52, Lactobacillus Brevis W63, Lactobacillus Casei W56, Lactococcus Lactis W19, Lactococcus Lactis W58, Lactobacillus Acidophilus W37, Bifidobacterium Bifidum W23, Bifidobacterium Lactis W51, and Lactobacillus Salivarius W24 on Metformin Tolerance and Efficacy With Microbiota and Stool Metabolome in Insulin-resistant Women - a 12-week Randomized, Placebo-controlled, Double-blind Study
- ClinicalTrials.gov ID
- NCT06092060
- Acronym / sponsor ID
- PoznanUPhyEd Probiotyk
- Conditions
- Insulin Resistance
- Keywords
- Insulin Resistance, Multistrain Probiotic, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 23 Oct 2023 (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 goal of this study is to evaluate the efficacy of metformin on insulin sensitivity and vascular endothelial function with respect to gut microbiota and metabolome in women with established insulin resistance and its tolerance after 12 weeks of probiotic therapy.
The hypothesis is probiotic therapy in women with established insulin resistance undergoing metformin treatment increases the drug's efficacy to improve insulin sensitivity and intestinal endothelial function, and reduces gastrointestinal side effects.
Study participants will be randomly assigned to 2 groups, taking a probiotic (GS) or a placebo (GP). The randomization scheme will be computer-generated using permuted blocks of block size 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the group GS | Experimental | Dietary Supplement: the group GS (probiotic)probiotic treatment group, ca. 20 participants |
| the group GP | Placebo comparator | Dietary Supplement: the group GP (placebo)placebo group, ca. 20 participants |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women 25-45 years old, menstruating, BMI 25-32.9 kg / m2, insulin resistance based on the HOMA-IR index (cut-off point 2.5
Key exclusion criteria (18 listed)
- type 1 and 2 diabetes,
- poorly controlled arterial hypertension (mean SBP values> 140mmHg and / or mean DBP values> 90mmHg) within the last month and / or the need to modify pharmacological treatment,
- 2nd degree obesity, BMI> 35 kg / m2,
- lipid disorders requiring pharmacological treatment in the last 3 months before the start of observation or during observation,
- positive history of ischemic heart disease, carotid and / or lower limb atherosclerosis,
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 |
|---|---|---|
| the group GS (probiotic)The probiotic-supplemented group will receive 2 capsules of freeze-dried powder of a probiotic mixture containing the following bacterial strains twice a day, 3-month: Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactococcus lactis W19, Lactococcus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Lactobacillus salivarius W24 | Dietary supplement | the group GS |
| the group GP (placebo)The placebo group will receive 2 capsules consisting of the probiotic product carrier, which is corn starch and maltodextrin, twice a day, 3-month. | Dietary supplement | the group GP |
Primary outcome
Qualitative assessment of intestinal microbiota in stool samples
Time frame: up to 10 months
gut bacteria species in stool will be assessed using the shallow shotgun sequencing method, NGS (Next Generation Sequencing)
Quantitive change in intestinal microbiota in stool samples
Time frame: up to 10 months
determination of quantitative (Colony forming units - CFU) changes in bacteria in the stool - the shallow shotgun sequencing method, NGS (Next Generation Sequencing) molecular analysis will be used to assess the changes
Intestinal metabolome in stool samples
Time frame: up to 10 months
metabolomic analysis (endogenous metabolism (catabolism of amino acids, lipids), biotransformation products under the influence of xenobiotics (e.g., caffeine), fatty acid biosynthesis, fatty acid derivatives, glycolysis, gluconeogenesis, biosynthesis of primary bile acids, amino acid metabolism, sphingolipid metabolism, unknown metabolites, non-targeted metabolome, short-chain fatty acids) will be performed on a quadrupole mass spectrometer coupled with a time-of-flight (QToF) analyzer connected to the AB Sciex - TripleTOF® 6600+ high performance liquid chromatograph (UHPLC)
Indicators of insulin sensitivity and carbohydrate metabolism
Time frame: up to 10 months
Analysis of biochemical indicators related to insulin resistance such as concentrations of glucose, insulin, insulin-like growth factor (IGF-1), hemoglobin A1C (HgA1C), myoglobin
Evaluation of indicators in stool
Time frame: up to 10 months
Determination of intestinal inflammatory index - fecal calprotectin, determination of intestinal permeability index - fecal zonulin and determination of intestinal membrane inflammatory index sIgA in feces (RT-PCR and Western blotting).
Indicators of lipid metabolism
Time frame: up to 10 months
Concentrations of total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, oxidatively modified LDL lipoprotein (oxLDL), paraoxonase (PON) activity, proprotein convertase subtilisin/kexin 9 (PCSK-9)
Transcription factors regulating carbohydrate and lipid metabolism
Time frame: up to 10 months
Peroxisome proliferator-activated receptor (PPARγ; NR1C3), PPARγ coactivator, coactivator 1 α ( PGC -1α)
Adipokines and myokines
Time frame: up to 10 months
Analysis of biochemical indicators related to insulin resistance such as leptin, adiponectin, resistin, wisfatin, retinol-binding protein type 4 (RBP4), lipocalin-2, proprotein convertase subtilisin/kexin type 9 (PCSK9)
Indicators of inflammation
Time frame: up to 10 months
C-reactive protein (hsCRP), interleukin-1 (IL-1), interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor (TNF-alpha), lipocalin-2
Indicators of vascular endothelial function
Time frame: up to 10 months
Analysis of biochemical indicators related to insulin resistance and endothelial function, such as endothelial nitric oxide synthase (eNOS), vascular endothelial growth factor (VEGF), homocysteine, plasminogen activator inhibitor 1 (PAI-1), adhesion molecules (sVCAM-1, ICAM-1), monocyte chemoattractant 1(MCP-1), matrix metalloproteinases (MMP-9 and MMP-2), cytosolic fatty acid binding proteins (FABPs)
Indicators of a disrupted intestinal barrier in the blood
Time frame: up to 10 months
zonulin, intestinal fatty acid binding protein (I-FABP)
4 secondary outcomes
Gastrointestinal disorders questionnaire
Time frame: up to 10 months
Body mass analysis (BMI, kg/m^2)
Time frame: up to 10 months
Body composition analysis (percent of total body mass
Time frame: up to 10 months
Composite measure of Diet composition assessed by food diaries
Time frame: up to 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 41852479Ratajczak M, Bilska A, Musialik K, Skonieczna-Zydecka K, Loniewski I, Gogojewicz A, Karolkiewicz J. Multi-strain probiotic reduces gastrointestinal side effects in women with elevated HOMA-IR index treated with metformin: a 12-week randomised controlled trial. Front Endocrinol (Lausanne). 2026 Mar 3;17:1765741. doi: 10.3389/fendo.2026.1765741. eCollection 2026.
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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.
Joanna Karolkiewicz, Prof principal investigator
Poznan University of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the group GS (probiotic) in people with Insulin Resistance, run by Poznan University of Physical Education 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 1 inclusion and 18 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: finished, as of the sponsor's last update on 23 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Qualitative assessment of intestinal microbiota in stool samples (time frame: up to 10 months). The study lists 11 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 NCT06092060, 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 23 Oct 2023.