Non Alcoholic Fatty LiverNCT05523024
Effect of Probiotics or Berberine in Hepatic Steatosis Markers, Cardiometabolic and Microbiotic Profile in NAFL.
A study testing Probiotic, Berberine and Probiotc and Berberine in people with Non Alcoholic Fatty Liver and Obesity, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Effect of oral selected Probiotics (PRO) and/or Berberine (BBR) supplementation on hepatic steatosis markers, cardiometabolic profile, and gut microbiota profile in the non-alcoholic fatty liver (NAFL) - a randomized double-blind clinical study. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Non Alcoholic Fatty Liver, Obesity
- What is being tested?
- Probiotic, Berberine and Probiotc and Berberine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 sitePoland
- Study dates
- 2 Aug 2022to 1 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 40 to 60 years;
- women ≥1 year since last menstruation;
- body mass index (BMI): 27.0 kg/m2 to 34.9 kg/m2;
- abdominal obesity-related waist circumference > 80 cm (women) and >94 cm (men) (in accordance to International Diabetes Federation);
- stable body weight in the 3 months prior to the trial (permissible deviation is ± 3 kg);
- NAFL - diagnosed based on USG in accordance with PGE-NAFLD recommendation
Who cannot join
- history of following alternative diets within 3 months before the study;
- history of use of any dietary supplements in the 3 months before the study;
- history of intake of antibiotics, probiotics, prebiotics within 3 months before the study;
- secondary form of obesity, pharmacological treatment for obesity (in the 3 months before the study), history of bariatric surgery;
- another liver diseases: high risk of NASH (assessed on the FIB-4, according to the PGE-NAFLD recommendation), autoimmune hepatitis, hepatitis B and C, toxic hepatitis, cirrhosis, Wilson's disease, hemochromatosis;
- other gastrointestinal disorders, especially: IBD, celiac disease, gastritis and duodenitis, pancreatic disorders, gastrointestinal symptoms suggestive of IBS;
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- clinically significant acute inflammatory process (elevated hsCRP);
- abnormal kidney function (GFR <60mL/min/1,73m2);
- T2D;
- dyslipidemia or hypertension - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
- pump inhibitors, anticoagulants, drugs causing metabolic alteration, e.g., SFAs (second-generation antipsychotics);
- diseases requiring nutritional requirement and chronic supplementation;
- alcohol (>30g/d for men and >20g/d for women), nicotine or drug abuse;
- mental disorders, including eating disorders;
- cancer, autoimmune diseases;
- any other condition which may influence on final results of the study or pose a risk for subjects health.
Trial locations and contacts
1 site in 1 country.
Monika Szulińska, DSc contact
Poland1 site, 1 recruiting
- Recruiting
2 Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznań University of Medical Sciences,
Poznan, 60-569
Małgorzata Moszak, PhD, +48-6185-49-377, mmoszak@ump.edu.pl
About this study
Official title: Effect of Probiotics or Berberine Supplementation on Hepatic Steatosis Markers, Cardiometabolic and Microbiotic Profile in NAFL - A Randomized Double- Blind Clinical Study.
Effect of oral selected Probiotics (PRO) and/or Berberine (BBR) supplementation on hepatic steatosis markers, cardiometabolic profile, and gut microbiota profile in the non-alcoholic fatty liver (NAFL) - a randomized double-blind clinical study.
Read the detailed description
Probiotics (PRO) and bioactive natural substances such as Berberine (BBR) can improve metabolic parameters in patients with obesity and metabolic disorders. In addition, they significantly affect the composition and function of gut microbiota (GM) and support anti-inflammation and antioxidant defense. These data have become the starting point for the proposed multidirectional approach, aimed at assessing the effect of PRO and/or BBR supplementation on:
- hepatic-related outcomes,
- changes in anthropometric measurements (body mass, BMI, body mass composition and fat mass % content),
- cardiometabolic profile (e.g. blood pressure, noninvasive markers of endothelial function, cardiometabolic biochemical parameters)
- microbiotic profile (gut microbiota composition, endotoxemia)
- the content of the minerals, in overweight/obese patients with nonalcoholic fatty liver (NAFL).
- Conditions
- Non Alcoholic Fatty Liver, Obesity
- Being tested
- Probiotic, Berberine, Placebo, Probiotc and Berberine
- Keywords
- NAFL; obesity; probiotics; berberine; microbiota;
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The probiotic group will receive one capsule of the probiotic mixture (dose:1x109 colony forming units (CFU) per day in one dose (before breakfast). The PRO preparation will contain the following bacterial strains: 50% Lactococcus lactis Rosell® - 1058, 25% Lactobacillus casei Rosell® - 215, 12,5% Lactobacillus helveticus Rosell® - 52, 12,5% Bifidobacterium bifidum Rosell® - 71). Probiotics will be administered orally.
BerberineDietary supplement
The berberine group will receive 1500 mg of Berberine (Berberine hydrochloride 97% extract of Berberis aristata) per day in 3 doses. Berberine will be administered orally, before breakfast, dinner, and before supper.
PlaceboDietary supplement
The placebo group will receive a placebo. Placebo will contain only the excipients and will be administered orally for 24 weeks. Placebo in no way: color, taste, smell, form of taking, the dosage will not differ from the preparations tested. However, it will not contain probiotcs or berberine. Placebo will be orally administered three times a day: before breakfast, dinner, and supper (6.00-7.00 p.m.). To meet the GCP conditions, subjects from all groups will receive the same number of capsules (six) per day.
Probiotc and BerberineDietary supplement
Probiotics and Berberine groupwill receive both: a probiotics mixture (as in PRO group: 1x109 CFU/day; in one dose) and 1500 mg/day of Berberine (Berberine hydrochloride 97% extract of Berberis aristata; in 3 doses). Probiotcs and berberine will be administered orally before breakfast, before dinner, and before supper.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Individuals receive Probiotics (9 strains: B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lactococcus lactis W19, and Lactococcus lactis W58) in dose: 1x109 colony forming units (CFU), daily, for 12 weeks.
Intervention: Dietary Supplement: Probiotic Receives: Dietary Supplement: Probiotic |
| Berberine | Active comparator | Individuals receive Berberine (Berberine hydrochloride 97% extract of Berberis aristata) in dose: 1500 mg/day, for 12 weeks.
Intervention: Dietary Supplement: Berberine Receives: Dietary Supplement: Berberine |
| Placebo | Placebo comparator | Individuals receive placebo daily, for 3 months. Intervention: Dietary Supplement: Placebo Receives: Dietary Supplement: Placebo |
| Probiotics and Berberine | Active comparator | Individuals receive: Probiotics (9 strains: B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lactococcus lactis W19, and Lactococcus lactis W58) in dose: 1x109 colony forming units (CFU), daily and Berberine (Berberine hydrochloride 97% extract of Berberis aristata) in dose: 1500 mg/day, for 12 weeks.
Intervention: Dietary Supplement: Probiotic and Berberine Receives: Dietary Supplement: Probiotc and Berberine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Fibrosis-4 (FIB-4) - Index for Liver Fibrosis.
FIB-4 will be estimated using a medical calculator (based on parameters as: age, ALT, AST, and platelet count).
Measured: At the baseline and 12 weeks of treatment
Changes in HSI - Hepatic Steatosis Index.
HSI will be estimated using a medical calculator (based on parameters as: gender, ALT, AST, BMI, and type 2 diabetes).
Measured: At the baseline and 12 weeks of treatment
Changes in NAFLD-LFS (liver fat score).
NAFLD-LFS will be estimated using a medical calculator (based on serum aspartate transaminase/alanine transaminase (AST/ALT) ratio, fasting serum aspartate transaminase (AST) level, fasting serum insulin level, presence of metabolic syndrome and diabetes mellitus).
Measured: At the baseline and 12 weeks of treatment
Secondary outcomes (28)
Changes in blood pressure.
Resting seated BP (both systolic and diastolic) will be measured using a brachial cuff (Omron Healthcare, Kyoto, Japan) three times at 2-min intervals, and the average value will be calculated.
Measured: At the baseline and 12 weeks of treatment
Changes in weight.
Weight will be measured in light clothing and without metal objects (i.e., belt, jewelry). Weight will be measured to the nearest 0.1 kg.
Measured: At the baseline and 12 weeks of treatment
Changes in waist circumference, hip circumference.
WC will be measured between the iliac crest and the lower rib at the end of a normal expiration, and HC will be measured around the widest portion of the buttocks. Both HC and WC will be measured using stretch-resistant medical tape (Seco) to the nearest 0.5 cm. The measurement of WC and HC will be performed according to the World Health Organization (WHO) protocol.
Measured: At the baseline and 12 weeks of treatment
Changes in waist to hip ratio.
WHR will be calculated as WC to HC quotient.
Measured: At the baseline and 12 weeks of treatment
Changes in BMI.
BMI will be calculated according to the formula: BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meters squared.
Measured: At the baseline and 12 weeks of treatment
Changes in fat mass content in the body.
The fat mass content [in kg] in the body will be estimated using BIA methods (InBody 270 and Bioscan 920-2),
Measured: At the baseline and 12 weeks of treatment
Changes in pulse wave velocity (PWV).
The pulse wave velocity (PWV) will be measured using the SphygmoCor Px (Atcor Medical Blood Pressure Analysis System, Sydney, Australia) in a temperature-controlled room before making anthropometric measurements and blood collection.
Measured: At the baseline and 12 weeks of treatment
Changes in pulse wave analysis (PWA).
The pulse wave analysis (PWA)will be measured using the SphygmoCor Px (Atcor Medical Blood Pressure Analysis System, Sydney, Australia) in a temperature-controlled room before making anthropometric measurements and blood collection.
Measured: At the baseline and 12 weeks of treatment
Gut (taxonomic and functional) microbiota analysis in stool.
Analyzed by the NGS method.
Measured: At the baseline and 12 weeks of treatment
Short-chain fatty acids (SCFAs) concentration in stool.
Analyzed using gas chromatography (Agilent Technologies 1260 A GC system with a flame ionization detector (FID))
Measured: At the baseline and 12 weeks of treatment
Measurement of hair minerals (Fe, Mg, Ca, Cu, Zn) concentration.
Performed using atomic absorption spectrometry (Atomic Absorption Spectrophotometer ZA3000, Hitachi, Tokyo, Japan)
Measured: At the baseline and 12 weeks of treatment
Changes in ALT, AST, GGT
The ALT, AST, GGT will be measured using standard methods.
Measured: At the baseline and 12 weeks of treatment
Changes in non-esterified free fatty acids.
The NEFA will be measured using standard methods.
Measured: At the baseline and 12 weeks of treatment
Changes in lipids profile (TC, HDL, TG).
The TC, HDL, TG will be measured using standard methods.
Measured: At the baseline and 12 weeks of treatment
Changes in low-density lipoprotein (LDL).
The low-density lipoprotein cholesterol (LDL) will be calculated according to the Friedwald equation.
Measured: At the baseline and 12 weeks of treatment
Changes in fasting glucose level.
The fasting glucose level will be measured using standard methods.
Measured: At the baseline and 12 weeks of treatment
Changes in fasting insulin level.
The ELISA will be used in the estimation.
Measured: At the baseline and 12 weeks of treatment
Changes in insulin resistance index (HOMA-IR)
The HOMA-IR will be calculated according to formula:
HOMA-IR = (insulin * glucose) / 22.5 for the glucose concentration in mmol/L, or: HOMA-IR = (insulin * glucose ) / 405 for glycemia in mg/dL. In both cases, the insulin is in mU/L.
Measured: At the baseline and 12 weeks of treatment
Changes in parameter of liver damage: cytokeratin 18.
The ELISA will be used in the estimation cytokeratin 18 (ccK18).
Measured: At the baseline and 12 weeks of treatment
Changes in parameter of liver damage: Glutathione S-transferase (GST).
The ELISA will be used in the estimation GST.
Measured: At the baseline and 12 weeks of treatment
Changes in parameter of liver damage: collagen IV.
The ELISA will be used in the estimation collagen IV.
Measured: At the baseline and 12 weeks of treatment
Changes in parameter of liver damage: hyaluronic acid.
The ELISA will be used in the estimation hyaluronic acid.
Measured: At the baseline and 12 weeks of treatment
Changes in hsCRP.
The hsCRP will be measured using ELISA.
Measured: At the baseline and 12 weeks of treatment
Changes in pentraxin 3.
The pentraxin 3 (PTX3) will be measured using ELISA.
Measured: At the baseline and 12 weeks of treatment
Gut barrier integrity parameter: calprotectin.
The ELISA, will be used in the estimation.
Measured: At the baseline and 12 weeks of treatment
Gut barrier integrity parameters: liver fatty acid-binding protein (L-FABP), intestinal fatty acid-binding protein (I-FABP).
The ELISA, will be used in the estimation.
Measured: At the baseline and 12 weeks of treatment
Gut barrier integrity parameters: lipopolysaccharide (LPS).
The ELISA, will be used in the estimation.
Measured: At the baseline and 12 weeks of treatment
Cardiometabolic risk.
Cardiometabolic risk will be estimated at baseline and after 3 months of treatment using the SCORE scale. SCORE scale summarize 5 risk factors (sex, age, systolic blood pressure, total cholesterol and smoking).
Measured: At the baseline and 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start2 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Alcoholic Fatty LiverStudies 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
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pawel Bogdanski, Poznan University of Medical Sciences
- Investigators
- Paweł Bogdański, Professor, Principal investigator, Poznan University of Medical Sciences, Poznan, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523024
- Sponsor's protocol ID
- 491/20;
- Status last verified
- Aug 2022
- First submitted
- 25 Apr 2022
- Last updated
- 31 Aug 2022
- 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 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics or Berberine Supplementation on Hepatic Steatosis Markers, Cardiometabolic and Microbiotic Profile in NAFL - A Randomized Double- Blind Clinical Study.
- ClinicalTrials.gov ID
- NCT05523024
- Acronym / sponsor ID
- 491/20;
- Conditions
- Non Alcoholic Fatty Liver, Obesity
- Keywords
- NAFL; obesity; probiotics; berberine; microbiota;
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 31 Aug 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.
Effect of oral selected Probiotics (PRO) and/or Berberine (BBR) supplementation on hepatic steatosis markers, cardiometabolic profile, and gut microbiota profile in the non-alcoholic fatty liver (NAFL) - a randomized double-blind clinical study.
Detailed description
Probiotics (PRO) and bioactive natural substances such as Berberine (BBR) can improve metabolic parameters in patients with obesity and metabolic disorders. In addition, they significantly affect the composition and function of gut microbiota (GM) and support anti-inflammation and antioxidant defense. These data have become the starting point for the proposed multidirectional approach, aimed at assessing the effect of PRO and/or BBR supplementation on:
- hepatic-related outcomes,
- changes in anthropometric measurements (body mass, BMI, body mass composition and fat mass % content),
- cardiometabolic profile (e.g. blood pressure, noninvasive markers of endothelial function, cardiometabolic biochemical parameters)
- microbiotic profile (gut microbiota composition, endotoxemia)
- the content of the minerals, in overweight/obese patients with nonalcoholic fatty liver (NAFL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: ProbioticIndividuals receive Probiotics (9 strains: B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lactococcus lactis W19, and Lactococcus lactis W58) in dose: 1x109 colony forming units (CFU), daily, for 12 weeks. Intervention: Dietary Supplement: Probiotic |
| Berberine | Active comparator | Dietary Supplement: BerberineIndividuals receive Berberine (Berberine hydrochloride 97% extract of Berberis aristata) in dose: 1500 mg/day, for 12 weeks. Intervention: Dietary Supplement: Berberine |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIndividuals receive placebo daily, for 3 months. Intervention: Dietary Supplement: Placebo |
| Probiotics and Berberine | Active comparator | Dietary Supplement: Probiotc and BerberineIndividuals receive: Probiotics (9 strains: B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lactococcus lactis W19, and Lactococcus lactis W58) in dose: 1x109 colony forming units (CFU), daily and Berberine (Berberine hydrochloride 97% extract of Berberis aristata) in dose: 1500 mg/day, for 12 weeks. Intervention: Dietary Supplement: Probiotic and Berberine |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age 40 to 60 years;
- women ≥1 year since last menstruation;
- body mass index (BMI): 27.0 kg/m2 to 34.9 kg/m2;
- abdominal obesity-related waist circumference > 80 cm (women) and >94 cm (men) (in accordance to International Diabetes Federation);
- stable body weight in the 3 months prior to the trial (permissible deviation is ± 3 kg);
Key exclusion criteria (16 listed)
- history of following alternative diets within 3 months before the study;
- history of use of any dietary supplements in the 3 months before the study;
- history of intake of antibiotics, probiotics, prebiotics within 3 months before the study;
- secondary form of obesity, pharmacological treatment for obesity (in the 3 months before the study), history of bariatric surgery;
- another liver diseases: high risk of NASH (assessed on the FIB-4, according to the PGE-NAFLD recommendation), autoimmune hepatitis, hepatitis B and C, toxic hepatitis, cirrhosis, Wilson's disease, hemochromatosis;
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 |
|---|---|---|
| ProbioticThe probiotic group will receive one capsule of the probiotic mixture (dose:1x109 colony forming units (CFU) per day in one dose (before breakfast). The PRO preparation will contain the following bacterial strains: 50% Lactococcus lactis Rosell® - 1058, 25% Lactobacillus casei Rosell® - 215, 12,5% Lactobacillus helveticus Rosell® - 52, 12,5% Bifidobacterium bifidum Rosell® - 71). Probiotics will be administered orally. | Dietary supplement | Probiotic |
| BerberineThe berberine group will receive 1500 mg of Berberine (Berberine hydrochloride 97% extract of Berberis aristata) per day in 3 doses. Berberine will be administered orally, before breakfast, dinner, and before supper. | Dietary supplement | Berberine |
| PlaceboThe placebo group will receive a placebo. Placebo will contain only the excipients and will be administered orally for 24 weeks. Placebo in no way: color, taste, smell, form of taking, the dosage will not differ from the preparations tested. However, it will not contain probiotcs or berberine. Placebo will be orally administered three times a day: before breakfast, dinner, and supper (6.00-7.00 p.m.). To meet the GCP conditions, subjects from all groups will receive the same number of capsules (six) per day. | Dietary supplement | Placebo |
| Probiotc and BerberineProbiotics and Berberine groupwill receive both: a probiotics mixture (as in PRO group: 1x109 CFU/day; in one dose) and 1500 mg/day of Berberine (Berberine hydrochloride 97% extract of Berberis aristata; in 3 doses). Probiotcs and berberine will be administered orally before breakfast, before dinner, and before supper. | Dietary supplement | Probiotics and Berberine |
Primary outcome
Changes in Fibrosis-4 (FIB-4) - Index for Liver Fibrosis.
Time frame: At the baseline and 12 weeks of treatment
FIB-4 will be estimated using a medical calculator (based on parameters as: age, ALT, AST, and platelet count).
Changes in HSI - Hepatic Steatosis Index.
Time frame: At the baseline and 12 weeks of treatment
HSI will be estimated using a medical calculator (based on parameters as: gender, ALT, AST, BMI, and type 2 diabetes).
Changes in NAFLD-LFS (liver fat score).
Time frame: At the baseline and 12 weeks of treatment
NAFLD-LFS will be estimated using a medical calculator (based on serum aspartate transaminase/alanine transaminase (AST/ALT) ratio, fasting serum aspartate transaminase (AST) level, fasting serum insulin level, presence of metabolic syndrome and diabetes mellitus).
28 secondary outcomes
Changes in blood pressure.
Time frame: At the baseline and 12 weeks of treatment
Changes in weight.
Time frame: At the baseline and 12 weeks of treatment
Changes in waist circumference, hip circumference.
Time frame: At the baseline and 12 weeks of treatment
Changes in waist to hip ratio.
Time frame: At the baseline and 12 weeks of treatment
Changes in BMI.
Time frame: At the baseline and 12 weeks of treatment
Changes in fat mass content in the body.
Time frame: At the baseline and 12 weeks of treatment
Changes in pulse wave velocity (PWV).
Time frame: At the baseline and 12 weeks of treatment
Changes in pulse wave analysis (PWA).
Time frame: At the baseline and 12 weeks of treatment
Gut (taxonomic and functional) microbiota analysis in stool.
Time frame: At the baseline and 12 weeks of treatment
Short-chain fatty acids (SCFAs) concentration in stool.
Time frame: At the baseline and 12 weeks of treatment
Measurement of hair minerals (Fe, Mg, Ca, Cu, Zn) concentration.
Time frame: At the baseline and 12 weeks of treatment
Changes in ALT, AST, GGT
Time frame: At the baseline and 12 weeks of treatment
Changes in non-esterified free fatty acids.
Time frame: At the baseline and 12 weeks of treatment
Changes in lipids profile (TC, HDL, TG).
Time frame: At the baseline and 12 weeks of treatment
Changes in low-density lipoprotein (LDL).
Time frame: At the baseline and 12 weeks of treatment
Changes in fasting glucose level.
Time frame: At the baseline and 12 weeks of treatment
Changes in fasting insulin level.
Time frame: At the baseline and 12 weeks of treatment
Changes in insulin resistance index (HOMA-IR)
Time frame: At the baseline and 12 weeks of treatment
Changes in parameter of liver damage: cytokeratin 18.
Time frame: At the baseline and 12 weeks of treatment
Changes in parameter of liver damage: Glutathione S-transferase (GST).
Time frame: At the baseline and 12 weeks of treatment
Changes in parameter of liver damage: collagen IV.
Time frame: At the baseline and 12 weeks of treatment
Changes in parameter of liver damage: hyaluronic acid.
Time frame: At the baseline and 12 weeks of treatment
Changes in hsCRP.
Time frame: At the baseline and 12 weeks of treatment
Changes in pentraxin 3.
Time frame: At the baseline and 12 weeks of treatment
Gut barrier integrity parameter: calprotectin.
Time frame: At the baseline and 12 weeks of treatment
Gut barrier integrity parameters: liver fatty acid-binding protein (L-FABP), intestinal fatty acid-binding protein (I-FABP).
Time frame: At the baseline and 12 weeks of treatment
Gut barrier integrity parameters: lipopolysaccharide (LPS).
Time frame: At the baseline and 12 weeks of treatment
Cardiometabolic risk.
Time frame: At the baseline and 12 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- 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.
Monika Szulińska, DSc contact
Paweł Bogdański, Professor principal investigator
Poznan University of Medical Sciences, Poznan, Poland
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, Berberine and Probiotc and Berberine in people with Non Alcoholic Fatty Liver and Obesity, run by Poznan University of Medical Sciences 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 6 inclusion and 16 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 31 Aug 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 Małgorzata Moszak, PhD (+48-6185-49-377, mmoszak@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Fibrosis-4 (FIB-4) - Index for Liver Fibrosis. (time frame: At the baseline and 12 weeks of treatment). The study lists 3 primary outcomes in all. 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 31 Aug 2022.