NASH - Nonalcoholic SteatohepatitisICANNCT04781933
Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement
A study testing Treatment with Combo in people with NASH - Nonalcoholic Steatohepatitis, run by Mativa-Tech SA at 2 sites in France.
Trial summary
The aim of this bicentre, prospective, placebo-controlled, double-blind, randomized, interventional study is to assess for the first time the effects of a Combo with probiotics and dietary supplements compared to placebo for non-alcoholic steatohepatitis (NASH) patients with mild or severe fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- Treatment with Combo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jan 2023to 1 Jan 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of moderate to severe NASH :
- chronic liver disease: biological abnormalities for more than 6 months characteristic ultrasound aspects
- metabolic syndrome
- liver stiffness assessed by FibroScan between 8 and 15kPa
- Adults
- Affiliated to a social security
- Women using effective contraception (hormonal or mechanical) for the duration of the srudy
Who cannot join
- Pregnancy
- Excessive alcohol consumption (>100g/week)
- Cirrhosis (elastometry > 15kPa)
- hepato-cellular carcinoma
- Hepatitis from Corticosteroids, Methotrexate, Amiodarone, Tamoxifen
- Viral hepatitis
Show all 11Show fewer
- Auto immune hepatitis
- anticoagulant therapy
- antibiotics in the month prior to inclusion
- allergic to soya, aspirin, fish, E110 dye, Maltodextrin
- poorly controlled diabetes (Glycated Hemoglobin >8%)
Trial locations and contacts
2 sites in 1 country.
Luc LEITZ contact
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Intercommunal Créteil
Créteil, 94010
Isabelle ROSA, MD, isabelle.rosa@chicreteil.fr
- Recruiting
Centre Hospitalier Intercommunal de Villeneuve St Georges
Villeneuve-Saint-Georges, 94190
Armand GARIOUD, PhD, armand.garioud@chiv.fr
About this study
The aim of this bicentre, prospective, placebo-controlled, double-blind, randomized, interventional study is to assess for the first time the effects of a Combo with probiotics and dietary supplements compared to placebo for non-alcoholic steatohepatitis (NASH) patients with mild or severe fibrosis.
Read the detailed description
Liver-related mortality is increased 10-fold in NASH patients compared with the general population. Currently, there are no established pharmacotherapies for NASH patients. The gut microbiota has a major contributing role in the development of NASH with leaky gut, inflammation, oxidative stress and impaired microbiota. Restoring the microbiota symbiosys could be a new way of resolution of NASH.
The aim of this trial is to evaluate the efficacy of the Combo, association of probiotics (Lactobacillus rhamnosus GG, Bifidobacterium breve BR03, Lactobacillus plantarum) and Glutamine, Quercetin, Vitamin E, Curcumin, Silybin, Pectin by means of histological resolution of NASH without progression of fibrosis, after 26 weeks (6 months), in 60 NASH patients with mild to severe fibrosis.
To confirm a histological diagnosis of NASH and proof efficacy of the Combo, a liver biopsy will be performed prior to screening as well as at the end of supplemental phase
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- Treatment with Combo, Treatment with placebo
- Keywords
- Combo, liver stiffness, gut microbiota, dietary supplements
- 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.
Treatment with ComboDietary supplement
Treatment with Combo
Treatment with placeboOther
Treatment with placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Combo | Active comparator | 3 dietary supplements will be given Receives: Dietary Supplement: Treatment with Combo |
| Treatment with Placebo | Placebo comparator | 3 placebos will be given Receives: Other: Treatment with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
NASH reduction: the main expected benefit is resolution of NASH, and no worsening of fibrosis
Evolution of the SAF score and CAP elastometry, a composite histological score taking into account the improvement of Steatosis, histological activity and liver fibrosis
Measured: At 6 months
Secondary outcomes (3)
Initial correlation of NASH parameters (FIB4, NAFLD and liver stiffness) and symbiosis parameters (stool analysis by Shallow Shotgun, biological data specific to symbiosis).
Measured: At the screening
Follow up of transaminase levels
Measured: At 6 months
Reduction of hepatic steatosis measured by CAP elastometry and Hepatic MRI
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Jan 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mativa-Tech SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Hervé Hagege, Centre Hospitalier Intercommunal Creteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781933
- Sponsor's protocol ID
- ICAN
- Acronym
- ICAN
- Status last verified
- Nov 2023
- First submitted
- 17 Feb 2021
- Last updated
- 7 Nov 2023
- 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 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement
- ClinicalTrials.gov ID
- NCT04781933
- Acronym / sponsor ID
- ICAN / ICAN
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Keywords
- Combo, liver stiffness, gut microbiota, dietary supplements
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mativa-Tech SAIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this bicentre, prospective, placebo-controlled, double-blind, randomized, interventional study is to assess for the first time the effects of a Combo with probiotics and dietary supplements compared to placebo for non-alcoholic steatohepatitis (NASH) patients with mild or severe fibrosis.
Detailed description
Liver-related mortality is increased 10-fold in NASH patients compared with the general population. Currently, there are no established pharmacotherapies for NASH patients. The gut microbiota has a major contributing role in the development of NASH with leaky gut, inflammation, oxidative stress and impaired microbiota. Restoring the microbiota symbiosys could be a new way of resolution of NASH.
The aim of this trial is to evaluate the efficacy of the Combo, association of probiotics (Lactobacillus rhamnosus GG, Bifidobacterium breve BR03, Lactobacillus plantarum) and Glutamine, Quercetin, Vitamin E, Curcumin, Silybin, Pectin by means of histological resolution of NASH without progression of fibrosis, after 26 weeks (6 months), in 60 NASH patients with mild to severe fibrosis.
To confirm a histological diagnosis of NASH and proof efficacy of the Combo, a liver biopsy will be performed prior to screening as well as at the end of supplemental phase
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Combo | Active comparator | Dietary Supplement: Treatment with Combo3 dietary supplements will be given |
| Treatment with Placebo | Placebo comparator | Other: Treatment with placebo3 placebos will be given |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of moderate to severe NASH :
- Adults
- Affiliated to a social security
- Women using effective contraception (hormonal or mechanical) for the duration of the srudy
Key exclusion criteria (11 listed)
- Pregnancy
- Excessive alcohol consumption (>100g/week)
- Cirrhosis (elastometry > 15kPa)
- hepato-cellular carcinoma
- Hepatitis from Corticosteroids, Methotrexate, Amiodarone, Tamoxifen
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 |
|---|---|---|
| Treatment with ComboTreatment with Combo | Dietary supplement | Treatment with Combo |
| Treatment with placeboTreatment with placebo | Other | Treatment with Placebo |
Primary outcome
NASH reduction: the main expected benefit is resolution of NASH, and no worsening of fibrosis
Time frame: At 6 months
Evolution of the SAF score and CAP elastometry, a composite histological score taking into account the improvement of Steatosis, histological activity and liver fibrosis
3 secondary outcomes
Initial correlation of NASH parameters (FIB4, NAFLD and liver stiffness) and symbiosis parameters (stool analysis by Shallow Shotgun, biological data specific to symbiosis).
Time frame: At the screening
Follow up of transaminase levels
Time frame: At 6 months
Reduction of hepatic steatosis measured by CAP elastometry and Hepatic MRI
Time frame: At 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- 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.
Luc LEITZ contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with Combo in people with NASH - Nonalcoholic Steatohepatitis, run by Mativa-Tech SA at 2 sites in France.
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 7 inclusion and 11 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 7 Nov 2023. 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 France. 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 Isabelle ROSA, Ph D (01 57 02 27 30, isabelle.rosa@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NASH reduction: the main expected benefit is resolution of NASH, and no worsening of fibrosis (time frame: At 6 months). 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 7 Nov 2023.