Decompensated CirrhosisPhase 2/3SIBOCNCT04775329
Primary Prophylaxis for Spontaneous Bacterial Peritonitis
A Phase 2/3 study testing Rifaximin in people with Decompensated Cirrhosis and Small Bowel Bacterial Overgrowth Syndrome, run by Changi General Hospital at 1 site in Singapore.
Trial summary
Patient with liver cirrhosis commonly have co-existing small bowel bacterial overgrowth (SIBO) yet may be asymptomatic. It is unclear as to the value of treating SIBO in asymptomatic individuals. Cirrhosis increase permeability of the gastrointestinal mucosa. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Decompensated Cirrhosis, Small Bowel Bacterial Overgrowth Syndrome
- What is being tested?
- Rifaximin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Nov 2020to 1 Jan 2023
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Decompensated liver cirrhosis (Childs B \& C) with ascites.
- Established diagnosis of SIBO
Who cannot join
- Known allergy to treatment drugs
- Inability to undergo test confirm the success of SIBO eradication;
- Pregnant or lactating women
- Terminal malignancy.
- Untreated Viral Hepatitis
- Alcoholic Liver disease with ongoing drinking.
- Respiratory Failure
- Recent antibiotics and proton-pump inhibitor within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary Prophylaxis for Spontaneous Bacterial Peritonitis in Decompensated Chronic Liver Disease With Small Bowel Bacterial Overgrowth: A Randomised Trial
Patient with liver cirrhosis commonly have co-existing small bowel bacterial overgrowth (SIBO) yet may be asymptomatic. It is unclear as to the value of treating SIBO in asymptomatic individuals. Cirrhosis increase permeability of the gastrointestinal mucosa. It is postulated that in cirrhosis, endotoxins translocate across the gut mucosal barrier resulting in a second hit within hepatocyte perpetuating decompensation and spontaneous bacterial peritonitis. We hypothesise that cirrhosis patients with concomitant SIBO are particularly vulnerable for endotoxin translocation and would benefit from treatment. Treatment of SIBO would reduce the risk of spontaneous bacterial peritonitis and other liver-related morbidities. We aim to treat a cohort of patients with severe liver disease and concomitant SIBO with antibiotics as prophylaxis and compare the risk of spontaneous bacterial peritonitis, further liver-related morbidity and survival against untreated asymptomatic controls.
- Being tested
- Rifaximin
- Keywords
- Rifaximin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Rifaximin 1000mg OM
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Standard of care |
| Treatment arm | Active comparator | Not described Receives: Drug: Rifaximin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Spontaneous bacterial peritonitis
To determine the rate of cirrhosis-related complications, with and without Rifaximin among decompensated cirrhosis with SIBO.
Measured: 12 months
Secondary outcomes (1)
Incidence of all liver related events (hepatic encephalopathy, variceal bleeding, acute on chronic liver failure)
To study and understand the immunophysiological and gut microbiota changes associated with bowel decontamination among cirrhosis patients with SIBO using serum biomarkers.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Nov 2020
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Why it stopped: Slow recruitment and study closure
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 Decompensated 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YU JUN WONG, MD, MRCP FAMS, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775329
- Sponsor's protocol ID
- SIBOC
- Acronym
- SIBOC
- Status last verified
- Jan 2023
- First submitted
- 25 Jan 2021
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.
PubMed 37467180
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Prophylaxis for Spontaneous Bacterial Peritonitis in Decompensated Chronic Liver Disease With Small Bowel Bacterial Overgrowth: A Randomised Trial
- ClinicalTrials.gov ID
- NCT04775329
- Acronym / sponsor ID
- SIBOC / SIBOC
- Keywords
- Rifaximin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment and study closure
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 1 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.
Patient with liver cirrhosis commonly have co-existing small bowel bacterial overgrowth (SIBO) yet may be asymptomatic. It is unclear as to the value of treating SIBO in asymptomatic individuals. Cirrhosis increase permeability of the gastrointestinal mucosa. It is postulated that in cirrhosis, endotoxins translocate across the gut mucosal barrier resulting in a second hit within hepatocyte perpetuating decompensation and spontaneous bacterial peritonitis. We hypothesise that cirrhosis patients with concomitant SIBO are particularly vulnerable for endotoxin translocation and would benefit from treatment. Treatment of SIBO would reduce the risk of spontaneous bacterial peritonitis and other liver-related morbidities. We aim to treat a cohort of patients with severe liver disease and concomitant SIBO with antibiotics as prophylaxis and compare the risk of spontaneous bacterial peritonitis, further liver-related morbidity and survival against untreated asymptomatic controls.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Standard of care |
| Treatment arm | Active comparator | Drug: Rifaximin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Decompensated liver cirrhosis (Childs B \& C) with ascites.
- Established diagnosis of SIBO
Key exclusion criteria (8 listed)
- Known allergy to treatment drugs
- Inability to undergo test confirm the success of SIBO eradication;
- Pregnant or lactating women
- Terminal malignancy.
- Untreated Viral Hepatitis
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 |
|---|---|---|
| RifaximinRifaximin 1000mg OM | Drug | Treatment arm |
Primary outcome
Incidence of Spontaneous bacterial peritonitis
Time frame: 12 months
To determine the rate of cirrhosis-related complications, with and without Rifaximin among decompensated cirrhosis with SIBO.
1 secondary outcome
Incidence of all liver related events (hepatic encephalopathy, variceal bleeding, acute on chronic liver failure)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Slow recruitment and study closure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Derived from this study: PubMed 37467180Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.
- Individual participant dataSharing planned: Undecided
Related trials for Decompensated Cirrhosis
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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.
YU JUN WONG, MD, MRCP FAMS principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rifaximin in people with Decompensated Cirrhosis and Small Bowel Bacterial Overgrowth Syndrome, run by Changi General Hospital at 1 site in Singapore.
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 8 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 6 Jan 2023. 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 Singapore. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Slow recruitment and study closure). 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?
Incidence of Spontaneous bacterial peritonitis (time frame: 12 months). 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 NCT04775329, 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 6 Jan 2023; AzTrials last refreshed its copy on 27 Oct 2026.