Non-Alcoholic Fatty Liver DiseasePhase 1/2NASHProNCT03511365
Effects of Probiotic on Inflammation and Microbiota in Patients With NASH
A Phase 1/2 study testing Probiotic Formulation VSL#3 in people with Non-Alcoholic Fatty Liver Disease and Probiotics MeSH Descriptor Data 2018, run by Northwell Health at 1 site in United States.
Trial summary
Individuals with clinically identified non-alcoholic fatty liver disease will undergo baseline evaluation of IL-17 and other inflammatory markers as well as microbiome determination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Probiotics MeSH Descriptor Data 2018, Interleukin-17 MeSH Descriptor Data 2018
- What is being tested?
- Probiotic Formulation VSL#3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2018to 11 Oct 2019
- Phase
- Phase 1/2
- 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
- 18 years of age or older
- Capable of giving informed consent
- Diagnosed with NAFLD as defined by the American Association for the Study of Liver Diseases (AASLD) who are treated or seen solely at the outpatient clinic at the Department of Hepatology at 400 Community Drive in Manhasset NY
Who cannot join
- Cirrhosis
- Absence of secondary causes of hepatic fat accumulation including:
- Excessive alcohol consumption
- Hepatitis C
- Wilson's Disease
- Lipodystrophy
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- Starvation
- Parenteral Nutrition
- Abetalipoproteinemia
- Specific Medications: Amiodarone, Methotrexate, Tamoxifen, Corticosteroids, Valproate, Anti-retroviral agents)
- Reye's Syndrome
- HELLP Syndrome
- Inborn errors of metabolism (LCAT deficiency, cholesterol ester storage disease, Wolman disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Alterations in Serum Inflammatory Markers and Fecal Microbiota Following Administration of the Probiotic Formulation VSL#3 in Patients With Nonalcoholic Fatty Liver Disease
Individuals with clinically identified non-alcoholic fatty liver disease will undergo baseline evaluation of IL-17 and other inflammatory markers as well as microbiome determination. The probiotic formulation VSL#3 450 Billion CFU twice daily will be administered for 8 weeks and the determination of Il-17 and microbiome will be repeated. Each subject will serve as his or her own control.
Read the detailed description
This study is designed as a prospective trial of the effects of probiotic on inflammatory and stool profiles in patients with NAFLD. These patients are actively followed by the Division of Hepatology. They will have confirmed normal liver function tests and absence of hepatitis C virus in order to be eligible for this study. Eligible subjects will be identified within the outpatient setting of the Division of Hepatology of the Northwell Health System.
Division of Hepatology 400 Community Drive Manhasset, NY 11030 516-562-4281
Candidate subjects will be identified by investigators as a part of their typical work flow. Subjects will be evaluated according to inclusion and exclusion criteria presented. Eligible patients will be provided with a packet containing study information and informed consent documents. Should a patient remain interested in study participation, informed consent will be obtained. Financial compensation will not be provided to subjects.
Forty patients with NAFLD will be enrolled.
Following enrollment and informed consent, subjects will undergo the following assessments:
- Medical History Questionnaire
- Current Medication List
Blood and stool samples will be obtained prior to study initiation and again after 8 weeks of exposure.
Protocol for biological sample collection:
Whole Blood Collection - Venipuncture will be performed under standard conditions. Three heparinized tubes will be obtained which each tube containing approximately 10 cc of whole blood Samples will be de-identified. Peripheral Blood Cells will be isolated from whole blood samples according to standard protocols.
Serum cytokine levels, including IL-10 and IL-17, will be assessed.
Stool Collection - Patients will be provided with stool collection kits. Samples will be de-identified. Stool samples will be preserved in a -20 degree freezer in the Division of Infectious Diseases.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Probiotics MeSH Descriptor Data 2018, Interleukin-17 MeSH Descriptor Data 2018
- Being tested
- Probiotic Formulation VSL#3
- Keywords
- Probiotic, Microbiome, Inflammation, Non-Alcoholic Fatty Liver Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Formulation VSL#3Biological
Probiotic VSL#3 administration.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic administration | Experimental | After baseline collection of serum and fecal microbiota, each subject will be administered the probiotic formulation VSL#3 450 Billion CFU Twice daily for 8 weeks. Serum and fecal microbiota will again be collected at the end of the intervention and compared with baseline with each subject serving as his or her own control. Receives: Biological: Probiotic Formulation VSL#3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Il-17 levels with probiotic administration
Percent decrease in Il levels will be recorded.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start15 May 2018
- Primary completion14 Dec 2018
- Study completion11 Oct 2019
Why it stopped: IRB haulted the study there was no evidence that the probiotic would benefit the patient
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 Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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 1/2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group interventional pilot study with each subject serving as his or her own control
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Hirsch, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511365
- Sponsor's protocol ID
- 17-0514
- Acronym
- NASHPro
- Status last verified
- Jan 2020
- First submitted
- 6 Apr 2018
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li J, Sung CY, Lee N, Ni Y, Pihlajamaki J, Panagiotou G, El-Nezami H. Probiotics modulated gut microbiota suppresses hepatocellular carcinoma growth in mice. Proc Natl Acad Sci U S A. 2016 Mar 1;113(9):E1306-15. doi: 10.1073/pnas.1518189113. Epub 2016 Feb 16.
PubMed 26884164
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Alterations in Serum Inflammatory Markers and Fecal Microbiota Following Administration of the Probiotic Formulation VSL#3 in Patients With Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03511365
- Acronym / sponsor ID
- NASHPro / 17-0514
- Conditions
- Non-Alcoholic Fatty Liver Disease, Probiotics MeSH Descriptor Data 2018, Interleukin-17 MeSH Descriptor Data 2018
- Keywords
- Probiotic, Microbiome, Inflammation, Non-Alcoholic Fatty Liver Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB haulted the study there was no evidence that the probiotic would benefit the patient
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 27 Apr 2018 (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.
Individuals with clinically identified non-alcoholic fatty liver disease will undergo baseline evaluation of IL-17 and other inflammatory markers as well as microbiome determination. The probiotic formulation VSL#3 450 Billion CFU twice daily will be administered for 8 weeks and the determination of Il-17 and microbiome will be repeated. Each subject will serve as his or her own control.
Detailed description
This study is designed as a prospective trial of the effects of probiotic on inflammatory and stool profiles in patients with NAFLD. These patients are actively followed by the Division of Hepatology. They will have confirmed normal liver function tests and absence of hepatitis C virus in order to be eligible for this study. Eligible subjects will be identified within the outpatient setting of the Division of Hepatology of the Northwell Health System.
Division of Hepatology 400 Community Drive Manhasset, NY 11030 516-562-4281
Candidate subjects will be identified by investigators as a part of their typical work flow. Subjects will be evaluated according to inclusion and exclusion criteria presented. Eligible patients will be provided with a packet containing study information and informed consent documents. Should a patient remain interested in study participation, informed consent will be obtained. Financial compensation will not be provided to subjects.
Forty patients with NAFLD will be enrolled.
Following enrollment and informed consent, subjects will undergo the following assessments:
- Medical History Questionnaire
- Current Medication List
Blood and stool samples will be obtained prior to study initiation and again after 8 weeks of exposure.
Protocol for biological sample collection:
Whole Blood Collection - Venipuncture will be performed under standard conditions. Three heparinized tubes will be obtained which each tube containing approximately 10 cc of whole blood Samples will be de-identified. Peripheral Blood Cells will be isolated from whole blood samples according to standard protocols.
Serum cytokine levels, including IL-10 and IL-17, will be assessed.
Stool Collection - Patients will be provided with stool collection kits. Samples will be de-identified. Stool samples will be preserved in a -20 degree freezer in the Division of Infectious Diseases.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group interventional pilot study with each subject serving as his or her own control
| Arm | Type | Receives |
|---|---|---|
| Probiotic administration | Experimental | Biological: Probiotic Formulation VSL#3After baseline collection of serum and fecal microbiota, each subject will be administered the probiotic formulation VSL#3 450 Billion CFU Twice daily for 8 weeks. Serum and fecal microbiota will again be collected at the end of the intervention and compared with baseline with each subject serving as his or her own control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Capable of giving informed consent
- Diagnosed with NAFLD as defined by the American Association for the Study of Liver Diseases (AASLD) who are treated or seen solely at the outpatient clinic at the Department of Hepatology at 400 Community Drive in Manhasset NY
Key exclusion criteria (13 listed)
- Cirrhosis
- Absence of secondary causes of hepatic fat accumulation including:
- Excessive alcohol consumption
- Hepatitis C
- Wilson's Disease
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 Formulation VSL#3Probiotic VSL#3 administration. | Biological | Probiotic administration |
Primary outcome
Change in Il-17 levels with probiotic administration
Time frame: 8 weeks
Percent decrease in Il levels will be recorded.
Results and safety
The study was stopped early (reason given: IRB haulted the study there was no evidence that the probiotic would benefit the patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Background: PubMed 26884164Li J, Sung CY, Lee N, Ni Y, Pihlajamaki J, Panagiotou G, El-Nezami H. Probiotics modulated gut microbiota suppresses hepatocellular carcinoma growth in mice. Proc Natl Acad Sci U S A. 2016 Mar 1;113(9):E1306-15. doi: 10.1073/pnas.1518189113. Epub 2016 Feb 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Probiotic Formulation VSL#3 in people with Non-Alcoholic Fatty Liver Disease and Probiotics MeSH Descriptor Data 2018, run by Northwell Health at 1 site in United States.
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 13 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: stopped early, as of the sponsor's last update on 7 Jan 2020. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: IRB haulted the study there was no evidence that the probiotic would benefit the patient). 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?
Change in Il-17 levels with probiotic administration (time frame: 8 weeks). 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 NCT03511365, 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 Jan 2020.