NAFLDNCT01922830
Probiotics and Microbiota in Bariatric Surgery
A study testing Bio-25 (Supherb) in people with NAFLD, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
This study is a randomized clinical trial with 6 months probiotic supplement vs. placebo treatment and 6 month follow up on 100 NAFLD patients that will undergo sleeve gastrectomy surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- NAFLD
- What is being tested?
- Bio-25 (Supherb)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2013to Jan 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 18-65 years old
- BMI > 40 kg/m² or BMI > 35 kg/m² with comorbidities (See Appendix 1 for the Ministry of health indications for bariatric surgeries) that got the bariatric commission approval of Assuta private hospitals to undergo sleeve gastrectomy surgery
- Willingness to take a probiotic/placebo supplement once a day for 6 months
- Ultrasound diagnosed NAFLD patients
- Reading and speaking Hebrew
- Healthy volunteers:
- Subjects 18-65 years old
- Healthy subjects
Who cannot join
- Subject with mental illness or cognitive deterioration
- Use of probiotic/antibiotic 3 mounts before surgery
- Use of other antibiotic for more than 1 week during the study
- Drug addiction
- Excessive alcohol consumption (≥ 30 g/day in men or ≥ 20 g/day in women)
- Treatment with drugs known to cause hepatic steatosis or elevation of liver enzymes (e.g. Corticosteroids, HAART, Amiodarone, high dose estrogens) (see Appendix 2)
Show all 12Show fewer
- Treatment with drugs or supplements that may improve hepatic steatosis or liver enzymes (Vitamin E, Milk thistle, ω-3 fatty acid, Ursodeoxycholic acid) 3 months prior to the initiation of the study
- Other causes of chronic liver disease ( e.g. viral hepatitis: HBV/HCV +, autoimmune hepatitis, Hemochromatosis, Wilson's disease)
- Diabetic patients who are treated with antidiabetic medications, except diabetic patients who are treated for at least 6 months exclusively with Metformin at a stable dose
- Subjects who began a new lipid reduction medications less than 6 months prior to the initiation of the study
- Subjects with chronic conditions that could interfere with our study: active cancer, organ transplant subjects, advanced kidney or liver disease, inflammatory bowel disease and other systemic inflammatory conditions
- Bariatric surgery in the past
Trial locations and contacts
1 site in 1 country.
About this study
This study is a randomized clinical trial with 6 months probiotic supplement vs. placebo treatment and 6 month follow up on 100 NAFLD patients that will undergo sleeve gastrectomy surgery. Measurements will be conducted at: baseline, M3 (3 months after treatment initiation), M6 and M12 and will include: abdominal US, Fibroscan, biochemical tests, anthropometric measurements, glucose breath test for bacterial overgrowth, fecal samples and questionnaires for demographic details, quality of life, food intake, food tolerance and habitual physical activity. 20 subjects will undergo an additional liver-MRI test at baseline and M6.
Additionally, 30 healthy participants will consume probiotic supplement vs. placebo for 28 days and will undergo gastroscopy and colonoscopy before and during consumption.
Read the detailed description
Background:
Bariatric surgery is an effective and increasingly common treatment for obesity and obesity-related comorbidities. Among patients undergoing bariatric surgery, as many as 96% have NAFLD (Nonalcoholic fatty liver disease) and up to 25% have NASH (Nonalcoholic steatohepatitis). Intestinal microbiota has been shown to play pivotal roles in host mammalian developmental, immune and metabolic functions. Alterations in the gut microbiome, or 'dysbiosis' has been recently linked to the pathogenesis of metabolic disease including obesity, insulin resistance, atherosclerosis and liver diseases. Recent studies show that modulation of gut microbiota may represent a novel way to treat or prevent NAFLD and its progression. Bariatric surgery is associated with major modifications in microbiota composition, quantity and function. Potential mediators to the gut microbiota are probiotics which are considered to be a safe therapy since its microorganisms composition is found naturally in human microflora. Clinical research has shown that probiotic supplementation can induce physiological changes in the intestinal flora (e.g., via the secretion of endogenic antibiotics and other defensins). Moreover, It was shown that probiotic bacteria are assimilated in the gut mucosa, thus replacing and changing the natural bacterial line-up. The biopsies taken in the healthy section of the study will help us evaluate all the above changes, after 4 weeks of probiotic intervention.
To date, there is lack of evidence on the use of probiotics in bariatric surgeries with just 1 randomizes clinical trial in Roux-en-Y gastric bypass surgery patients.
Aims:
To evaluate the effect of 6 months probiotic supplement vs. placebo on clinical and metabolic parameters in patients with NAFLD undergoing sleeve gastrectomy surgery.
Working hypothesis: Modulation of gut microbiota with probiotic will have a beneficial effect on clinical and metabolic parameters in sleeve gastrectomy patients with NAFLD.
To evaluate the effect of 4 weeks probiotic supplement vs. placebo on microbiome composition and function in healthy volunteers.
Methods:
A randomized double blind clinical trial with 6 months treatment and 6 months follow up including 2 treatment arms: probiotic and placebo. One hundred NAFLD patients who will undergo sleeve gastrectomy surgery through the bariatric surgery clinic at the Tel Aviv Assuta medical center will be enrolled during 2013-2016. Baseline and follow up evaluation will be performed at the Tel-Aviv Sourasky Medical center and will include: abdominal US (hepato-renal index-HRI), Fibroscan, biochemical tests, anthropometric measurements, glucose breath test for bacterial overgrowth (BO). Fecal samples will be collected and analyzed for gut microbiota utilizing 'state of the art' molecular methods. All patients will fill out validated questionnaires of demographic details, quality of life, food intake, food tolerance and habitual physical activity. Measurements will be conducted at: baseline, M3 (3 months after treatment initiation), M6 and M12. 20 subjects will undergo an additional liver-MRI test at baseline and M6.
Importance of the study: Almost all morbid obese patients have NAFLD and up to 25% have NASH, leading to major hepatic and extra-hepatic complications. Only limited data are available concerning gut microbiota composition after bariatric surgery and its association with weight reduction, metabolic and hepatic parameters. Moreover, there are no clinical trials on the role of probiotics administration following sleeve gastrectomy bariatric surgery on hepatic parameters. Probiotic supplement after bariatric surgery may improve the therapeutic effect of the surgery on hepatic steatosis and may improve also biochemical tests of vitamins (e.g. B12), inflammatory mediators (e.g. endotoxin levels) and metabolic parameters, reduce bacterial overgrowth and enhance weight loss. The study would help in developing new treatment approaches and will contribute to the understanding of the mechanisms underlying the hepatic, metabolic and inflammatory consequences of bariatric surgery.
Probiotic supplement vs. placebo will be given to 30 healthy participants. participants will undergo gastroscopy (upper GI endoscopy) + colonoscopy (lower GI endoscopy) before the probiotics intervention and after 3 to 4 weeks of probiotic intervention. During the procedure, biopsies will be taken from different segments of the GI tract. The study samples will be frozen performing the microbial tests. In addition, participants will collect fecal samples. In this section, participants will be followed-up for 3 months.
- Conditions
- NAFLD
- Being tested
- Bio-25 (Supherb), Placebo (for Bio-25, Supherb)
- Keywords
- Sleeve Gastrectomy, NAFLD, gut microbiot, Bariatric surgery
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-25 (Supherb)Dietary supplement
The Bio-25 (Supherb) is a probiotic supplement consisting of 11 different species of patented probiotic bacteria and over 25 billion active bacteria in each capsule. The bacteria in the formula are patented bacteria that have undergone drying, freezing, and double coating which ensures their survival under stomach acidity conditions and their enrooting in the intestines.
Placebo (for Bio-25, Supherb)Dietary supplement
A pill manufactured to mimic Bio-25 (Supherb) pill
| Study group | Role | What they receive |
|---|---|---|
| Bio-25 (Supherb) | Experimental | Bio-25 (Supherb) once daily (2 capsules -50 billion bacteria) for 6 months (or 4 weeks for healthy participants).
The Bio-25 (Supherb) is a probiotic supplement consisting of 11 different species of patented probiotic bacteria and over 25 billion active bacteria in each capsule. The bacteria in the formula are patented bacteria that have undergone drying, freezing, and double coating which ensures their survival under stomach acidity conditions and their enrooting in the intestines. Receives: Dietary Supplement: Bio-25 (Supherb) |
| Placebo | Placebo comparator | Identical placebo once daily (2 capsules) for 6 months (or 4 weeks for healthy participants).
The placebo supplementation is identical-looking to the Bio-25 supplement. Receives: Dietary Supplement: Placebo (for Bio-25, Supherb) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepato-Renal Index (HRI) method by abdominal US
US will be performed at pretrial, 6 ,12 , 36 months after the surgery. .Fatty liver will be diagnosed by abdominal US using standardized criteria. HRI, a validated quantitative measure, will be calculated on the basis of the ratio between the echogenicity of the liver and that of the right kidney cortex using histogram echo intensity.
Measured: 36 months
Secondary outcomes (9)
Liver fibrosis - by Fibroscan (transient elastography)
The liver stiffness will be measured by Fibroscan (using XL probe) and will be performed at pretrial, 6 and 12 month after the surgery. The liver stiffness is measured by Fibroscan in a volume of approximates 1 cm wide and 4 cm long cylinder, representing 1/500 of liver tissue (100 times greater than a biopsy sample). The results of the Fibroscan test are expressed in KiloPascals (kPa). The Fibroscan XL probe reduces Fibroscan failure and facilitates reliable liver stiffness measurement in obese patients compared with the common M probe.
Measured: 36 months
Anthropometric measurements
Measurements of anthropometry will be performed following a uniform protocol at pretrial, 3, 6 and 12 month after the surgery. Height, weight, WC (Waist circumference) will be measured. BMI and %EWL will be calculated. "Tanita" will be used for body composition analysis (%fat mass, fat mass and fat free mass) and will be performed at pretrial and 6 month after the surgery.
Measured: 36 months
Biochemical fasting blood tests
Patients will undergo biochemical tests at pretrial, 3, 6 ,12, 36 months after the surgery. All blood samples will be drawn at the morning after a fast of at least 12 hours. Serological tests that will be taken: lipid profile, inflammatory factors (CRP, TNF-α, IL6, IL10, TGF- β), adipocytokines (leptin, adiponectin), endotoxin (Lipopolysacchride), hepatocyte apoptosis markers (CK-18, sFas), glucose, HbA1C, total bilirubin, liver enzymes, TSH, insulin, vitamin B1, vitamin B12, vitamin D, Iron, ferritin, folic acid. HOMA will be calculated as: serum insulin (μIU/ml) x plasma glucose (mmol/l)/22.5. HOMA index ≥2.77 is considered to be diagnostic for insulin resistance.
Measured: 36 months
The fecal microbiota composition
Fecal samples will be taken at pretrial and 6 month after the surgery. Fecal samples will be obtained in the morning before breakfast. The stools will be self-collected in sterile boxes that will be given to the participants in advance and will be stored at -800C degrees until further analysis. DNA will be extract from feces for detecting microbiota diversion. Philogenetic analysis will be performed using pyrosequencing and multiplexing of bacterial 16S rRNA segments. Samples from several randomly selected individuals will be used for shotgutn metagenomic sequencing.
Measured: 6 years
Quality of life (QoL)
Patients will fill out a self-reported QoL questionnaire at pretrial, 3, 6 , 12, 36 month after the surgery. The SF-12 (a shorter version of the SF-36) is a QoL questionnaire. The SF-12 yields 2 summary scores: physical component summary (PCS) and mental component summary (MCS). The SF-12 have been translated and validated in many languages (including Hebrew) and were found valid and reliable among the general population. Higher scores on the PCS and MCS indicate better health.
Measured: 36 months
Food tolerance after bariatric surgery
Patients will fill out a self-reported questionnaire for quick assessment of food tolerance after bariatric surgery at pretrial, 3, 6 and 12 month after the surgery. To evaluate food tolerance we will use this questionnaire which was previously described by Suter et al. This questionnaire is simple to fill out, reliable, and useful both in following up individuals after bariatric surgery and in comparing results after different procedures as part of the evaluation of QoL . The score for this questionnaire is divided into 3 parts: Patient's satisfaction of their food intake, food tolerance (for 8 different types of food) and the frequency of vomiting/regurgitation.
Measured: 36 months
Liver MRI
20 subjects will undergo an additional liver-MRI test at baseline and M6.
Measured: 6 months
Hand grip
For hand dynamometer a standard chair with a straight back without arm rests is needed. The participant sits in a chair with his/her feet flat on the floor and his/her knees at 90-degree angle. The arm being tested should be at a 90-degree angle, next to but not touching his body. The tester demonstrates the test and then the participant does a practice trial on the dominant and then the non-dominant hand. After the practice trial the examiner will put the dynamometer in the participants dominant hand and with saying "Go" the subject will squeeze his hand as hard as possible for 3-4 seconds till examiner says 'stop'. The maximum reading will be recorded. The participant will then perform the test once more on the non-dominant hand. Measurement will be recorded. A 2 trials / hand (15 seconds rest between trails) will be performed in alternate fashion and best score (in kg) will be recorded.
Measured: 36 months
Microbiome composition and function
Gastrointestinal tract biopsies, fecal samples
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
- Investigators
- Oren Shibolet, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922830
- Sponsor's protocol ID
- TASMC-13-OS-196-CTIL
- Status last verified
- Jul 2018
- First submitted
- 12 Aug 2013
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Sherf-Dagan S, Zelber-Sagi S, Buch A, Bar N, Webb M, Sakran N, Raziel A, Goitein D, Keidar A, Shibolet O. Prospective Longitudinal Trends in Body Composition and Clinical Outcomes 3 Years Following Sleeve Gastrectomy. Obes Surg. 2019 Dec;29(12):3833-3841. doi: 10.1007/s11695-019-04057-2.
PubMed 31301031Shenhar-Tsarfaty S, Sherf-Dagan S, Berman G, Webb M, Raziel A, Keidar A, Goitein D, Sakran N, Zwang E, Shapira I, Zeltser D, Berliner S, Rogowski O, Shibolet O, Zelber-Sagi S. Obesity-related acetylcholinesterase elevation is reversed following laparoscopic sleeve gastrectomy. Int J Obes (Lond). 2019 Feb;43(2):297-305. doi: 10.1038/s41366-018-0014-4. Epub 2018 Feb 3.
PubMed 29491490Sherf Dagan S, Zelber-Sagi S, Webb M, Keidar A, Raziel A, Sakran N, Goitein D, Shibolet O. Nutritional Status Prior to Laparoscopic Sleeve Gastrectomy Surgery. Obes Surg. 2016 Sep;26(9):2119-2126. doi: 10.1007/s11695-016-2064-9.
PubMed 26797718
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics and Microbiota in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01922830
- Acronym / sponsor ID
- TASMC-13-OS-196-CTIL
- Conditions
- NAFLD
- Keywords
- Sleeve Gastrectomy, NAFLD, gut microbiot, Bariatric surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Oct 2013
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 14 Aug 2013 (estimated)
- 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 is a randomized clinical trial with 6 months probiotic supplement vs. placebo treatment and 6 month follow up on 100 NAFLD patients that will undergo sleeve gastrectomy surgery. Measurements will be conducted at: baseline, M3 (3 months after treatment initiation), M6 and M12 and will include: abdominal US, Fibroscan, biochemical tests, anthropometric measurements, glucose breath test for bacterial overgrowth, fecal samples and questionnaires for demographic details, quality of life, food intake, food tolerance and habitual physical activity. 20 subjects will undergo an additional liver-MRI test at baseline and M6.
Additionally, 30 healthy participants will consume probiotic supplement vs. placebo for 28 days and will undergo gastroscopy and colonoscopy before and during consumption.
Detailed description
Background:
Bariatric surgery is an effective and increasingly common treatment for obesity and obesity-related comorbidities. Among patients undergoing bariatric surgery, as many as 96% have NAFLD (Nonalcoholic fatty liver disease) and up to 25% have NASH (Nonalcoholic steatohepatitis). Intestinal microbiota has been shown to play pivotal roles in host mammalian developmental, immune and metabolic functions. Alterations in the gut microbiome, or 'dysbiosis' has been recently linked to the pathogenesis of metabolic disease including obesity, insulin resistance, atherosclerosis and liver diseases. Recent studies show that modulation of gut microbiota may represent a novel way to treat or prevent NAFLD and its progression. Bariatric surgery is associated with major modifications in microbiota composition, quantity and function. Potential mediators to the gut microbiota are probiotics which are considered to be a safe therapy since its microorganisms composition is found naturally in human microflora. Clinical research has shown that probiotic supplementation can induce physiological changes in the intestinal flora (e.g., via the secretion of endogenic antibiotics and other defensins). Moreover, It was shown that probiotic bacteria are assimilated in the gut mucosa, thus replacing and changing the natural bacterial line-up. The biopsies taken in the healthy section of the study will help us evaluate all the above changes, after 4 weeks of probiotic intervention.
To date, there is lack of evidence on the use of probiotics in bariatric surgeries with just 1 randomizes clinical trial in Roux-en-Y gastric bypass surgery patients.
Aims:
To evaluate the effect of 6 months probiotic supplement vs. placebo on clinical and metabolic parameters in patients with NAFLD undergoing sleeve gastrectomy surgery.
Working hypothesis: Modulation of gut microbiota with probiotic will have a beneficial effect on clinical and metabolic parameters in sleeve gastrectomy patients with NAFLD.
To evaluate the effect of 4 weeks probiotic supplement vs. placebo on microbiome composition and function in healthy volunteers.
Methods:
A randomized double blind clinical trial with 6 months treatment and 6 months follow up including 2 treatment arms: probiotic and placebo. One hundred NAFLD patients who will undergo sleeve gastrectomy surgery through the bariatric surgery clinic at the Tel Aviv Assuta medical center will be enrolled during 2013-2016. Baseline and follow up evaluation will be performed at the Tel-Aviv Sourasky Medical center and will include: abdominal US (hepato-renal index-HRI), Fibroscan, biochemical tests, anthropometric measurements, glucose breath test for bacterial overgrowth (BO). Fecal samples will be collected and analyzed for gut microbiota utilizing 'state of the art' molecular methods. All patients will fill out validated questionnaires of demographic details, quality of life, food intake, food tolerance and habitual physical activity. Measurements will be conducted at: baseline, M3 (3 months after treatment initiation), M6 and M12. 20 subjects will undergo an additional liver-MRI test at baseline and M6.
Importance of the study: Almost all morbid obese patients have NAFLD and up to 25% have NASH, leading to major hepatic and extra-hepatic complications. Only limited data are available concerning gut microbiota composition after bariatric surgery and its association with weight reduction, metabolic and hepatic parameters. Moreover, there are no clinical trials on the role of probiotics administration following sleeve gastrectomy bariatric surgery on hepatic parameters. Probiotic supplement after bariatric surgery may improve the therapeutic effect of the surgery on hepatic steatosis and may improve also biochemical tests of vitamins (e.g. B12), inflammatory mediators (e.g. endotoxin levels) and metabolic parameters, reduce bacterial overgrowth and enhance weight loss. The study would help in developing new treatment approaches and will contribute to the understanding of the mechanisms underlying the hepatic, metabolic and inflammatory consequences of bariatric surgery.
Probiotic supplement vs. placebo will be given to 30 healthy participants. participants will undergo gastroscopy (upper GI endoscopy) + colonoscopy (lower GI endoscopy) before the probiotics intervention and after 3 to 4 weeks of probiotic intervention. During the procedure, biopsies will be taken from different segments of the GI tract. The study samples will be frozen performing the microbial tests. In addition, participants will collect fecal samples. In this section, participants will be followed-up for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-25 (Supherb) | Experimental | Dietary Supplement: Bio-25 (Supherb)Bio-25 (Supherb) once daily (2 capsules -50 billion bacteria) for 6 months (or 4 weeks for healthy participants). The Bio-25 (Supherb) is a probiotic supplement consisting of 11 different species of patented probiotic bacteria and over 25 billion active bacteria in each capsule. The bacteria in the formula are patented bacteria that have undergone drying, freezing, and double coating which ensures their survival under stomach acidity conditions and their enrooting in the intestines. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo (for Bio-25, Supherb)Identical placebo once daily (2 capsules) for 6 months (or 4 weeks for healthy participants). The placebo supplementation is identical-looking to the Bio-25 supplement. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects 18-65 years old
- BMI > 40 kg/m² or BMI > 35 kg/m² with comorbidities (See Appendix 1 for the Ministry of health indications for bariatric surgeries) that got the bariatric commission approval of Assuta private hospitals to undergo sleeve gastrectomy surgery
- Willingness to take a probiotic/placebo supplement once a day for 6 months
- Ultrasound diagnosed NAFLD patients
- Reading and speaking Hebrew
Key exclusion criteria (12 listed)
- Subject with mental illness or cognitive deterioration
- Use of probiotic/antibiotic 3 mounts before surgery
- Use of other antibiotic for more than 1 week during the study
- Drug addiction
- Excessive alcohol consumption (≥ 30 g/day in men or ≥ 20 g/day in women)
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 |
|---|---|---|
| Bio-25 (Supherb)The Bio-25 (Supherb) is a probiotic supplement consisting of 11 different species of patented probiotic bacteria and over 25 billion active bacteria in each capsule. The bacteria in the formula are patented bacteria that have undergone drying, freezing, and double coating which ensures their survival under stomach acidity conditions and their enrooting in the intestines. | Dietary supplement | Bio-25 (Supherb) |
| Placebo (for Bio-25, Supherb)A pill manufactured to mimic Bio-25 (Supherb) pill | Dietary supplement | Placebo |
Primary outcome
Hepato-Renal Index (HRI) method by abdominal US
Time frame: 36 months
US will be performed at pretrial, 6 ,12 , 36 months after the surgery. .Fatty liver will be diagnosed by abdominal US using standardized criteria. HRI, a validated quantitative measure, will be calculated on the basis of the ratio between the echogenicity of the liver and that of the right kidney cortex using histogram echo intensity.
9 secondary outcomes
Liver fibrosis - by Fibroscan (transient elastography)
Time frame: 36 months
Anthropometric measurements
Time frame: 36 months
Biochemical fasting blood tests
Time frame: 36 months
The fecal microbiota composition
Time frame: 6 years
Quality of life (QoL)
Time frame: 36 months
Food tolerance after bariatric surgery
Time frame: 36 months
Liver MRI
Time frame: 6 months
Hand grip
Time frame: 36 months
Microbiome composition and function
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Derived from this study: PubMed 31301031Sherf-Dagan S, Zelber-Sagi S, Buch A, Bar N, Webb M, Sakran N, Raziel A, Goitein D, Keidar A, Shibolet O. Prospective Longitudinal Trends in Body Composition and Clinical Outcomes 3 Years Following Sleeve Gastrectomy. Obes Surg. 2019 Dec;29(12):3833-3841. doi: 10.1007/s11695-019-04057-2.
- Derived from this study: PubMed 29491490Shenhar-Tsarfaty S, Sherf-Dagan S, Berman G, Webb M, Raziel A, Keidar A, Goitein D, Sakran N, Zwang E, Shapira I, Zeltser D, Berliner S, Rogowski O, Shibolet O, Zelber-Sagi S. Obesity-related acetylcholinesterase elevation is reversed following laparoscopic sleeve gastrectomy. Int J Obes (Lond). 2019 Feb;43(2):297-305. doi: 10.1038/s41366-018-0014-4. Epub 2018 Feb 3.
- Derived from this study: PubMed 26797718Sherf Dagan S, Zelber-Sagi S, Webb M, Keidar A, Raziel A, Sakran N, Goitein D, Shibolet O. Nutritional Status Prior to Laparoscopic Sleeve Gastrectomy Surgery. Obes Surg. 2016 Sep;26(9):2119-2126. doi: 10.1007/s11695-016-2064-9.
Related trials for NAFLD
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)
Not yet recruitingPhase 2
Qurse Revand for MASLD: A Randomized Controlled Safety and Efficacy Trial
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
RecruitingPhase 2
Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
Non-Alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease
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.
Oren Shibolet, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bio-25 (Supherb) in people with NAFLD, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 8 inclusion and 12 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 19 Jul 2018. 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 Israel. 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?
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?
Hepato-Renal Index (HRI) method by abdominal US (time frame: 36 months). 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 NCT01922830, which also lists 3 linked publications.
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 19 Jul 2018.