AzTrials
AzTrials

Liver DiseasePhase 1NCT00808990

The Effect of Probiotics on Non Alcoholic Fatty Liver Disease

A Phase 1 study testing BioFemale in people with Liver Disease, run by Rabin Medical Center at 1 site in Israel.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Nonalcoholic Fatty Liver Disease (NAFLD) has been suggested to be the most common cause of chronic liver disease in the general population in the Western World. In advanced stages of NAFLD, steatohepatitis (NASH) develops characterized by: steatosis, inflammation, and fibrosis progressing to cirrhosis in some… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Liver Disease
What is being tested?
BioFemale
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteIsrael
Study dates
Feb 2013to Sep 2015
Phase
Phase 1
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Controls- healthy volunteers, male and female, above 18 years.
  • NAFLD group - patients with histological proven NAFLD, male and female, above 18 years.

Who cannot join

  • Controls
  • those who will be found to have fatty liver in abdominal ultra sound
  • any participant who will take antibiotics for any indication for more than 1 week during the study period or before recruitment to the study
  • any participant who had lost more than 10% of baseline body weight during the study period.
  • NAFLD group
  • those who will be found to have any concomitant liver disease (i.e., HBV/HCV/HIV/EBV/CMV infection
Show all 10Show fewer
  • autoimmune hepatitis
  • metabolic liver disease: Wilson's disease, cholestatic liver disease: PBC/PSC, etc.)
  • any participant who will take antibiotics for any indication for more than 1 week during the study period or before recruitment to the study
  • any participant who had lost more than 10% of baseline body weight during the study period

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Rabin Medical Center

    Petah Tikva, 49100

Other trials in Israel

About this study

Official title: Probiotics and Non Alcoholic Steatohepatitis (NASH)

Nonalcoholic Fatty Liver Disease (NAFLD) has been suggested to be the most common cause of chronic liver disease in the general population in the Western World. In advanced stages of NAFLD, steatohepatitis (NASH) develops characterized by: steatosis, inflammation, and fibrosis progressing to cirrhosis in some patients. The knowledge of the role of small intestinal bacterial overgrowth (SIBO) in the pathogenesis of NASH has led to the proposal of probiotics as a therapeutic strategy for this disorder.

Read the detailed description

Probiotics may interfere with the development of NASH by several mechanisms. Data from an uncontrolled clinical trial in NASH patients show promising results, with improvement of liver enzymes in treated patients.

RESEARCH GOALS:

  1. To assess the degree of SIBO in NAFLD patients vs. healthy controls. B. To evaluate the effect of probiotics vs. placebo on SIBO in NAFLD patients. C. To evaluate the effect of probiotics vs. placebo on disease severity (inflammation, steatosis, and fibrosis) in NAFLD patients.
Conditions
Liver Disease
Being tested
BioFemale
Keywords
Non Alcoholic Fatty Liver Disease, Non Alcoholic SteatoHepatitis, Small bowel bacterial overgrowth, Probiotics, Patients with Non Alcoholic Fatty Liver Disease
Medical subject headings
Liver Diseases, Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BioFemaleDietary supplement

    BioFemale 6 months.

Study groups in NCT00808990
Study groupRoleWhat they receive
OSA and NAFLD patients using CPAPExperimentalOSA and NAFLD patients using CPAP being followed for 6 months.
Receives: Dietary Supplement: BioFemale
controlNo interventionOSA and NAFLD patients not using CPAP being followed for 6 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SIBO in NASH patients in both treated groups (probiotics treated versus placebo treated) will be evaluated by lactulose breath test

    Measured: Recruitment period of 6 months and 6 months of treatment after each recruitment

  2. Lactulose breath test

    Measured: Measurement at recruitment (0) and at the end of treatment period (6 mo)

Secondary outcomes (2)

  1. FIBROMAX tests will assess severity of NAFLD in patients' group prior to treatment and post treatment

    Measured: At recruitment to the study (0) and at the end of treatment (6 mo)

  2. Fibromax test for the evaluation of NAFLD severity

    Measured: At the recruitment (0) and at the end of treatment (6 mo)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2008 (estimated)
  2. Study startFeb 2013
  3. Primary completionAug 2015
  4. Study completionSep 2015

Why it stopped: Time table was unfulfilled due to incompetent research coordinator. Inaccurate results and No conclusions can be withdrawn

Resources

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00808990
Sponsor's protocol ID
RMC085077CTIL
Other IDs
RMC local ID 5077
Status last verified
Apr 2016
First submitted
15 Dec 2008
Last updated
8 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • Li Z, Yang S, Lin H, Huang J, Watkins PA, Moser AB, Desimone C, Song XY, Diehl AM. Probiotics and antibodies to TNF inhibit inflammatory activity and improve nonalcoholic fatty liver disease. Hepatology. 2003 Feb;37(2):343-50. doi: 10.1053/jhep.2003.50048.

    PubMed 12540784

  • Loguercio C, De Simone T, Federico A, Terracciano F, Tuccillo C, Di Chicco M, Carteni M. Gut-liver axis: a new point of attack to treat chronic liver damage? Am J Gastroenterol. 2002 Aug;97(8):2144-6. doi: 10.1111/j.1572-0241.2002.05942.x. No abstract available.

    PubMed 12190198

  • Khoshini R, Dai SC, Lezcano S, Pimentel M. A systematic review of diagnostic tests for small intestinal bacterial overgrowth. Dig Dis Sci. 2008 Jun;53(6):1443-54. doi: 10.1007/s10620-007-0065-1.

    PubMed 17990113

  • Nair S, Cope K, Risby TH, Diehl AM. Obesity and female gender increase breath ethanol concentration: potential implications for the pathogenesis of nonalcoholic steatohepatitis. Am J Gastroenterol. 2001 Apr;96(4):1200-4. doi: 10.1111/j.1572-0241.2001.03702.x.

    PubMed 11316170

  • Yang SQ, Lin HZ, Lane MD, Clemens M, Diehl AM. Obesity increases sensitivity to endotoxin liver injury: implications for the pathogenesis of steatohepatitis. Proc Natl Acad Sci U S A. 1997 Mar 18;94(6):2557-62. doi: 10.1073/pnas.94.6.2557.

    PubMed 9122234

  • Chitturi S, Farrell GC. Etiopathogenesis of nonalcoholic steatohepatitis. Semin Liver Dis. 2001;21(1):27-41. doi: 10.1055/s-2001-12927.

    PubMed 11296694

  • Wigg AJ, Roberts-Thomson IC, Dymock RB, McCarthy PJ, Grose RH, Cummins AG. The role of small intestinal bacterial overgrowth, intestinal permeability, endotoxaemia, and tumour necrosis factor alpha in the pathogenesis of non-alcoholic steatohepatitis. Gut. 2001 Feb;48(2):206-11. doi: 10.1136/gut.48.2.206.

    PubMed 11156641

  • Solga SF, Buckley G, Clark JM, Horska A, Diehl AM. The effect of a probiotic on hepatic steatosis. J Clin Gastroenterol. 2008 Nov-Dec;42(10):1117-9. doi: 10.1097/MCG.0b013e31816d920c. No abstract available.

    PubMed 18936646

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BioFemale in people with Liver Disease, run by Rabin 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 2 inclusion and 10 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 8 Apr 2016. 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. 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 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.

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: Time table was unfulfilled due to incompetent research coordinator. Inaccurate results and No conclusions can be withdrawn). 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?

SIBO in NASH patients in both treated groups (probiotics treated versus placebo treated) will be evaluated by lactulose breath test (time frame: Recruitment period of 6 months and 6 months of treatment after each recruitment). The study lists 2 primary outcomes in all. 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 NCT00808990, which also lists 8 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 8 Apr 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in