Liver CirrhosisNCT00312910
Probiotics for the Prevention of Major Complications of Cirrhosis
A study testing Probiotics-Bio-plus in people with Liver Cirrhosis, run by Meir Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether probiotics are effective in the prevention of the complications of liver cirrhosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Probiotics-Bio-plus
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2005to Oct 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with liver cirrhosis with at least one of the followings
- 1)Major complication of cirrhosis in the past (including variceal bleeding, encephalopathy and SBP) 2)Evidence for portal hypertension 3)Reduced hepatic synthetic function
- -
Who cannot join
- Patients with alcoholic cirrhosis who still consume alcohol
- Patients that are chronically treated with antibiotics or lactulose -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether probiotics are effective in the prevention of the complications of liver cirrhosis.
Read the detailed description
Colonic bacteria clearly play a major role in the pathogenesis of major complications in patients with liver cirrhosis. By producing ammonia and endotoxins they can cause hepatic encephalopathy , and their translocation from the gut to the peritoneal cavity is the major mechanism for spontaneous bacterial peritonitis. There are also new studies suggesting a possible connection between bacterial translocation and bleeding from esophageal varices. Some of the therapeutic measures for the treatment and prevention of complications in cirrhotic patients, such as antibiotics and lactulose, are partially directed against gut bacteria.
In recent years there is a growing interest in the effect of probiotic bacteria on gut flora and prevention of infection. They were found to prevent pediatric infectious diarrhea and antibiotic-associated diarrhea- especially those caused by Clostridium difficile.
The probiotic bacteria, among which the most common are the lactose fermenting Lactobacilli, inhibit the growth of pathogenic bacteria by acidifying the gut lumen, competing for nutrients, and by producing antimicrobial substances. They adhere to the gut mucosa and by that are thought to prevent bacterial translocation from the gut. These effects of probiotics raised the idea that they may have a role in the treatment and prevention of cirrhosis complications. A recent study examined the effect of probiotics on patients with minimal chronic hepatic encephalopathy. Hepatic encephalopathy was reversed in 50% of the patients receiving probiotics. These patients also demonstrated a significant reduction of blood levels of ammonia, bilirubin and ALT, and of pathologic bacteria in stool cultures. This study showed promising results but was carried out on a relatively small population. Furthermore, the effect of probiotics on the prevention of hepatic encephalopathy and other major complications of cirrhosis has not been studied yet. Therefore, more studies are needed to establish the role of probiotics in patients with cirrhosis.
- Conditions
- Liver Cirrhosis
- Being tested
- Probiotics-Bio-plus
- Keywords
- Cirrhosis, Probiotics, Hepatic encephalopathy, Ammonia
- Medical subject headings
- Liver Cirrhosis, Fibrosis, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics-Bio-plusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of probiotics on the rate of complications of liver cirrhosis (variceal bleeding, hepatic encephalopathy, SBP)
Secondary outcomes (3)
Hospital Admissions due to complications of cirrhosis
Ammonia blood levels
Hepatic and renal function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2006 (estimated)
- Study startApr 2005
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ambrosia - SupHerb Ltd.
- Investigators
- David Pereg, MD, Principal investigator, Meir Medical Center, Kfar-Sava, IsraelYona Kitay-Cohen, MD, Principal investigator, Meir Medical Center, Kfar-Sava, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312910
- Sponsor's protocol ID
- MeirMc-05DP2907-CTIL
- Status last verified
- Apr 2007
- First submitted
- 9 Apr 2006
- Last updated
- 22 May 2008
- Results posted
- No
Publications
Liu Q, Duan ZP, Ha DK, Bengmark S, Kurtovic J, Riordan SM. Synbiotic modulation of gut flora: effect on minimal hepatic encephalopathy in patients with cirrhosis. Hepatology. 2004 May;39(5):1441-9. doi: 10.1002/hep.20194.
PubMed 15122774Pereg D, Kimhi O, Tirosh A, Orr N, Kayouf R, Lishner M. The effect of fermented yogurt on the prevention of diarrhea in a healthy adult population. Am J Infect Control. 2005 Mar;33(2):122-5. doi: 10.1016/j.ajic.2004.11.001.
PubMed 15761413Szajewska H, Kotowska M, Mrukowicz JZ, Armanska M, Mikolajczyk W. Efficacy of Lactobacillus GG in prevention of nosocomial diarrhea in infants. J Pediatr. 2001 Mar;138(3):361-5. doi: 10.1067/mpd.2001.111321.
PubMed 11241043Pochapin M. The effect of probiotics on Clostridium difficile diarrhea. Am J Gastroenterol. 2000 Jan;95(1 Suppl):S11-3. doi: 10.1016/s0002-9270(99)00809-6.
PubMed 10634221
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics for the Prevention of Major Complications of Cirrhosis
- ClinicalTrials.gov ID
- NCT00312910
- Acronym / sponsor ID
- MeirMc-05DP2907-CTIL
- Conditions
- Liver Cirrhosis
- Keywords
- Cirrhosis, Probiotics, Hepatic encephalopathy, Ammonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Ambrosia - SupHerb Ltd.
- Study start
- Apr 2005
- Study completion
- Oct 2007 (actual)
- First posted
- 11 Apr 2006 (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 purpose of this study is to determine whether probiotics are effective in the prevention of the complications of liver cirrhosis.
Detailed description
Colonic bacteria clearly play a major role in the pathogenesis of major complications in patients with liver cirrhosis. By producing ammonia and endotoxins they can cause hepatic encephalopathy , and their translocation from the gut to the peritoneal cavity is the major mechanism for spontaneous bacterial peritonitis. There are also new studies suggesting a possible connection between bacterial translocation and bleeding from esophageal varices. Some of the therapeutic measures for the treatment and prevention of complications in cirrhotic patients, such as antibiotics and lactulose, are partially directed against gut bacteria.
In recent years there is a growing interest in the effect of probiotic bacteria on gut flora and prevention of infection. They were found to prevent pediatric infectious diarrhea and antibiotic-associated diarrhea- especially those caused by Clostridium difficile.
The probiotic bacteria, among which the most common are the lactose fermenting Lactobacilli, inhibit the growth of pathogenic bacteria by acidifying the gut lumen, competing for nutrients, and by producing antimicrobial substances. They adhere to the gut mucosa and by that are thought to prevent bacterial translocation from the gut. These effects of probiotics raised the idea that they may have a role in the treatment and prevention of cirrhosis complications. A recent study examined the effect of probiotics on patients with minimal chronic hepatic encephalopathy. Hepatic encephalopathy was reversed in 50% of the patients receiving probiotics. These patients also demonstrated a significant reduction of blood levels of ammonia, bilirubin and ALT, and of pathologic bacteria in stool cultures. This study showed promising results but was carried out on a relatively small population. Furthermore, the effect of probiotics on the prevention of hepatic encephalopathy and other major complications of cirrhosis has not been studied yet. Therefore, more studies are needed to establish the role of probiotics in patients with cirrhosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with liver cirrhosis with at least one of the followings
- 1)Major complication of cirrhosis in the past (including variceal bleeding, encephalopathy and SBP) 2)Evidence for portal hypertension 3)Reduced hepatic synthetic function
- -
Key exclusion criteria (2 listed)
- Patients with alcoholic cirrhosis who still consume alcohol
- Patients that are chronically treated with antibiotics or lactulose -
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 |
|---|---|---|
| Probiotics-Bio-plus | Drug | – |
Primary outcome
The effect of probiotics on the rate of complications of liver cirrhosis (variceal bleeding, hepatic encephalopathy, SBP)
3 secondary outcomes
Hospital Admissions due to complications of cirrhosis
Ammonia blood levels
Hepatic and renal function
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 22 May 2008.
- Background: PubMed 15122774Liu Q, Duan ZP, Ha DK, Bengmark S, Kurtovic J, Riordan SM. Synbiotic modulation of gut flora: effect on minimal hepatic encephalopathy in patients with cirrhosis. Hepatology. 2004 May;39(5):1441-9. doi: 10.1002/hep.20194.
- Background: PubMed 15761413Pereg D, Kimhi O, Tirosh A, Orr N, Kayouf R, Lishner M. The effect of fermented yogurt on the prevention of diarrhea in a healthy adult population. Am J Infect Control. 2005 Mar;33(2):122-5. doi: 10.1016/j.ajic.2004.11.001.
- Background: PubMed 11241043Szajewska H, Kotowska M, Mrukowicz JZ, Armanska M, Mikolajczyk W. Efficacy of Lactobacillus GG in prevention of nosocomial diarrhea in infants. J Pediatr. 2001 Mar;138(3):361-5. doi: 10.1067/mpd.2001.111321.
- Background: PubMed 10634221Pochapin M. The effect of probiotics on Clostridium difficile diarrhea. Am J Gastroenterol. 2000 Jan;95(1 Suppl):S11-3. doi: 10.1016/s0002-9270(99)00809-6.
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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.
David Pereg, MD principal investigator
Meir Medical Center, Kfar-Sava, Israel
Yona Kitay-Cohen, MD principal investigator
Meir Medical Center, Kfar-Sava, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics-Bio-plus in people with Liver Cirrhosis, run by Meir 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 3 inclusion and 2 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 22 May 2008. 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.
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?
The effect of probiotics on the rate of complications of liver cirrhosis (variceal bleeding, hepatic encephalopathy, SBP). 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 NCT00312910, which also lists 4 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 22 May 2008.