Non-alcoholic Fatty Liver DiseasePhase 2NucesNASHNCT02366052
Nutritional Counseling vs. Nutritional Supplements for NASH - a Randomized Prospective, Open Label Pilot Study
A Phase 2 study testing Nutritional Counseling, Lactobacillus casei shirota (LCS) and Nutritional Counseling and LCS in people with Non-alcoholic Fatty Liver Disease and Fatty Liver, Nonalcoholic, run by Johannes Gutenberg University Mainz at 2 sites in Germany.
Trial summary
The main aim of the study is to determine if an oral supplementation of the LCS has a beneficial effect by itself or even enhances the beneficial effects of a moderate life-style intervention on the progression of NAFLD in humans. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic
- What is being tested?
- Nutritional Counseling, Lactobacillus casei shirota (LCS) and Nutritional Counseling and LCS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Feb 2015to 10 May 2017
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elevated M30 antigen levels (cutoff: >200 - 800 U/L) at screening AND hepatic steatosis on ultrasound
- OR histologically confirmed NASH
- Age 18 to 75 years
Who cannot join
- Alcohol intake of more than 30 g/d (men) or 20 g/d (women)
- Treatment with ursodeoxycholic acid (UDCA), Vitamin E or other investigational NASH drugs 3 months prior to randomization
- Treatment with medications or substances that may induce secondary NASH (e.g., tamoxifen, corticosteroids, amiodarone, methotrexate) or ameliorate NASH (TNF-antagonists)
- Treatment with phenprocoumon or warfarin
- Hepatocellular carcinoma or non-hepatic malignancy
- Decompensated cirrhosis (Child B,C) or a history of decompensation
Show all 19Show fewer
- Liver disease unrelated to NASH, including chronic viral hepatitis B/D or C, autoimmune hepatitis, Wilson's disease or clinical manifest iron overload
- Bariatric surgery within the last 5 years
- BMI <18,5 kg/m2 or BMI >45 kg/m2
- Liver transplantation
- Heart failure (New York Heart Association Class II - IV)
- Myocardial infarction, instable coronary artery disease , coronary artery intervention or stroke in the previous 6 months
- Instable chronic obstructive pulmonary disease, chronic inflammatory bowel disease or rheumatoid arthritis.
- Instable renal insufficiency (changes in serum creatinin > 50% in the last 3 month) or terminal renal insufficiency requiring dialysis
- Uncontrolled hypertension (blood pressure > 180/90 despite therapy)
- Uncontrolled diabetes mellitus defined by hemoglobin A1c > 9
- Food allergies requiring strictly dietary adherence
- Pregnant or nursing women
- Chronic pancreatitis or history of recurring acute pancreatitis
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Institut für Ernährungswissenschaften, University Jena
Jena, 07743
University Medical Center of the Johannes Gutenber Univeristy
Mainz, 55131
About this study
Official title: Nutritional Counseling Versus Nutritional Supplements for the Treatment of NASH - a Randomized Prospective, Open Label Pilot Study (Nuces NASH)
The main aim of the study is to determine if an oral supplementation of the LCS has a beneficial effect by itself or even enhances the beneficial effects of a moderate life-style intervention on the progression of NAFLD in humans.
- Being tested
- Nutritional Counseling, Lactobacillus casei shirota (LCS), Nutritional Counseling and LCS
- Keywords
- Histologically confirmed NASH, Hepatocyte Injury determined by M30 antigen
- 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.
Nutritional CounselingBehavioural
Nutritional counseling by a trained nutritionist for 12 weeks.
Lactobacillus casei shirota (LCS)Dietary supplement
Also called Yakult plus
The dietary supplement LCS (Yakult plus) will be given 2 times a day for 12 weeks in addition to dietary counseling every 3 weeks.
Nutritional Counseling and LCSOther
Also called Nutritional Counseling and Yakult plus
Nutritional counseling by a trained nutritionist in addition to the dietary supplement LCS (2 times a day) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Counseling | Active comparator | The nutritional counseling group will receive dietary counseling focusing on a reduction of fructose intake by a trained nutritionist for 12 weeks every 3 weeks. Receives: Behavioral: Nutritional Counseling |
| Nutritional Counseling and LCS | Experimental | The dietary supplement LCS (Lactobacillus casei shirota ) will be given 2 times a day for 12 weeks in addition to the nutritional counseling every 3 weeks. Receives: Other: Nutritional Counseling and LCS |
| Lactobacillus Casei Shirota | Experimental | The dietary supplement LCS (Lactobacillus casei shirota ) will be given 2 times a day for 12 weeks. Receives: Dietary Supplement: Lactobacillus casei shirota (LCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the M30 antigen in the serum
Reduction of the M30 antigen as a validated measure of the degree of hepatocellular inflammation and injury
Measured: 12 and 24 weeks
Secondary outcomes (3)
Change in indicators of hepatocellular injury and fibrosis
Change in indicators of hepatocellular injury (ALT, gammaGT, M30/M60 antigen ratio, ELF score), proinflammatory cytokines (hsCRP, ferritin, plasminogen activator-1, endotoxin), surrogate parameters of liver fibrosis (fibrosis marker panels, Fibrotest, ELF score) and relative liver stiffness (assessed by Fibro Scan)
Measured: 12 and 24 weeks
Change in metabolic risk factors
Changes in metabolic risk factors (BMI, waist circumference, Homeostasis Model Assessment/Matsuda Score, serum lipids), changes in oral glucose tolerance and changes in hepatic steatosis will be assessed.
Measured: 12 and 24 weeks
Saftey and tolerability
Safety is assessed by (1) clinical examination, (2) clinical chemistries including serum electrolytes, renal, liver function tests and markers of pancreatic injury.
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study start1 Feb 2015
- Primary completion10 May 2017
- Study completion10 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jena
- Responsible party
- Principal investigator, Priv.-Doz. Dr. J. Schattenberg, Johannes Gutenberg University Mainz
- Investigators
- Jörn M Schattenberg, MD, Principal investigator, Johannes Gutenberg UniversitätIna Bergheim, PhD, Principal investigator, Universität Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366052
- Sponsor's protocol ID
- NUCES_NASH-JGU
- Other IDs
- SCHA 1015/5-1
- Acronym
- NucesNASH
- Status last verified
- May 2017
- First submitted
- 1 Nov 2013
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Counseling Versus Nutritional Supplements for the Treatment of NASH - a Randomized Prospective, Open Label Pilot Study (Nuces NASH)
- ClinicalTrials.gov ID
- NCT02366052
- Acronym / sponsor ID
- NucesNASH / NUCES_NASH-JGU
- Keywords
- Histologically confirmed NASH, Hepatocyte Injury determined by M30 antigen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- University of Jena
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 19 Feb 2015 (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.
The main aim of the study is to determine if an oral supplementation of the LCS has a beneficial effect by itself or even enhances the beneficial effects of a moderate life-style intervention on the progression of NAFLD in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nutritional Counseling | Active comparator | Behavioral: Nutritional CounselingThe nutritional counseling group will receive dietary counseling focusing on a reduction of fructose intake by a trained nutritionist for 12 weeks every 3 weeks. |
| Nutritional Counseling and LCS | Experimental | Other: Nutritional Counseling and LCSThe dietary supplement LCS (Lactobacillus casei shirota ) will be given 2 times a day for 12 weeks in addition to the nutritional counseling every 3 weeks. |
| Lactobacillus Casei Shirota | Experimental | Dietary Supplement: Lactobacillus casei shirota (LCS)The dietary supplement LCS (Lactobacillus casei shirota ) will be given 2 times a day for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elevated M30 antigen levels (cutoff: >200 - 800 U/L) at screening AND hepatic steatosis on ultrasound
- OR histologically confirmed NASH
- Age 18 to 75 years
Key exclusion criteria (19 listed)
- Alcohol intake of more than 30 g/d (men) or 20 g/d (women)
- Treatment with ursodeoxycholic acid (UDCA), Vitamin E or other investigational NASH drugs 3 months prior to randomization
- Treatment with medications or substances that may induce secondary NASH (e.g., tamoxifen, corticosteroids, amiodarone, methotrexate) or ameliorate NASH (TNF-antagonists)
- Treatment with phenprocoumon or warfarin
- Hepatocellular carcinoma or non-hepatic malignancy
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 |
|---|---|---|
| Nutritional CounselingNutritional counseling by a trained nutritionist for 12 weeks. | Behavioural | Nutritional Counseling |
| Lactobacillus casei shirota (LCS)Also: Yakult plusThe dietary supplement LCS (Yakult plus) will be given 2 times a day for 12 weeks in addition to dietary counseling every 3 weeks. | Dietary supplement | Lactobacillus Casei Shirota |
| Nutritional Counseling and LCSAlso: Nutritional Counseling and Yakult plusNutritional counseling by a trained nutritionist in addition to the dietary supplement LCS (2 times a day) for 12 weeks. | Other | Nutritional Counseling and LCS |
Primary outcome
Reduction of the M30 antigen in the serum
Time frame: 12 and 24 weeks
Reduction of the M30 antigen as a validated measure of the degree of hepatocellular inflammation and injury
3 secondary outcomes
Change in indicators of hepatocellular injury and fibrosis
Time frame: 12 and 24 weeks
Change in metabolic risk factors
Time frame: 12 and 24 weeks
Saftey and tolerability
Time frame: 12 and 24 weeks
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 16 May 2017.
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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.
Jörn M Schattenberg, MD principal investigator
Johannes Gutenberg Universität
Ina Bergheim, PhD principal investigator
Universität Jena
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nutritional Counseling, Lactobacillus casei shirota (LCS) and Nutritional Counseling and LCS in people with Non-alcoholic Fatty Liver Disease and Fatty Liver, Nonalcoholic, run by Johannes Gutenberg University Mainz at 2 sites in Germany.
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 19 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 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 phase mean?
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 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?
Reduction of the M30 antigen in the serum (time frame: 12 and 24 weeks). 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 16 May 2017.