Small Intestinal Bacterial OvergrowthNCT02439307
Effycacy of Rifaximin on Reverse Minimal Hepatic Encephalopathy and Elimation Small Intestinal Bacterial
A study testing Rifaximin in people with Small Intestinal Bacterial Overgrowth and Liver Cirrhosis, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
A total of 46 patients diagnosed with liver cirrhosis will be recruited. All patients will be evaluated with five psychometric tests and critical flicker frequency to diagnosis minimal hepatic encephalopathy (MHE). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Small Intestinal Bacterial Overgrowth, Liver Cirrhosis
- What is being tested?
- Rifaximin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteMexico
- Study dates
- 28 Feb 2017to 26 Jul 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cirrhosis of any etiology
- Men and women between 18 and 70 years.
- Patients diagnosed with minimal hepatic encephalopathy and small intestinal bacterial overgrowth
- Right-holders of the Mexican Social Security Institute
- Patients who agree to participate in the study and signed the informed consent
Who cannot join
- Recent history of alcohol abuse and/or drugs (less than 6 weeks).
- Illiterate
- Alcoholic cirrhosis
- History and/or diagnosis of overt hepatic encephalopathy
- Consumption of psychotropic medications (benzodiazepines, antiepileptics)
- Patients under treatment with lactulose, lacitol, rifaximin, neomycin, metronidazole and/or fiber supplements.
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- History of chronic renal disease or heart failure
- Patients with gastrointestinal bleeding
- History of neurological or psychiatric disorders that affect the ability to develop neuropsychological tests
- Patients with diarrhea
- Diagnosis of liver cancer
- Patients with ophthalmologic disorders
- Patients taking antibiotics 30 days before the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Rifaximin on Minimal Hepatic Encephalopathy and Small Intestinal Bacterial Overgrowth in Patients With Cirrhosis
A total of 46 patients diagnosed with liver cirrhosis will be recruited. All patients will be evaluated with five psychometric tests and critical flicker frequency to diagnosis minimal hepatic encephalopathy (MHE). A breath test sample will be performed in all patients with MHE with 10 g of lactulose to establish the diagnosis of small intestinal bacterial overgrowth (SIBO). Patients diagnosed with EHM and SIBO will be randomized to receive per day 1200 mg of rifaximin (group A) or placebo (group B) for 2 weeks. A complete medical history, nutritional assessment, biochemical studies, and evaluation of quality of life will be performed in all patients included in the study. Besides the initial visit, patients will receive subsequent care 2, 4, 8, 12, and 24 weeks after the beginning of the study.
Read the detailed description
MHE impairs the quality of life, increases the risk of motor vehicle accidents, and mortality. Currently, there is no consensus on treatment and yet there are few proven treatment options. Among the factors associated with MHE, is the small intestinal bacterial overgrowth (SIBO) present in 38.6% of patients with MHE. Rifaximin is a broad spectrum antimicrobial administered orally, with low risk of inducing bacterial resistance, and has been used in the treatment of MHE. It is unknown if the beneficial effect on MHE is associated with the elimination of SIBO and its efficacy when administered in patients with simultaneous diagnosis of MHE and SIBO was never been evaluated. The aim of our study is to evaluate the effect of rifaximin on MHE and SIBO in patients with cirrhosis.
- Being tested
- Rifaximin, Placebo
- Keywords
- Rifaximin, Minimal hepatic encephalopathy
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Also called Antibiotic
1200 mg of rifaximin for 2 weeks.
PlaceboDrug
Also called Action lacks substance
Placebo for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin | Active comparator | Patients will receive per day 1200 mg of rifaximin Receives: Drug: Rifaximin |
| Placebo | Placebo comparator | Patients will receive a placebo of rifaximin Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal of small intestinal bacterial overgrowth
Analyze the number of patients who reverts the small intestinal bacterial overgrowth after the study
Measured: 2 weeks
Secondary outcomes (2)
Quality of life improvement
Analyze the number of patients who improve the record of quality of life, that will be evaluated with the Chronic Liver Disease Questionnaire
Measured: 2 weeks
Reversal of minimal hepatic encephalopathy
Analyze the number of patients who reverts the minimal hepatic encephalopathy
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start28 Feb 2017
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Why it stopped: The study was terminated because of the reconversion of the hospital to care for patients with COVID19. For this reason, it was not possible to continue recruiting and monitoring patients for this clinical study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestinal Bacterial OvergrowthStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Segundo Moran Villota, Coordinación de Investigación en Salud, Mexico
- Investigators
- Segundo Moran, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439307
- Sponsor's protocol ID
- F-CNIC-2013-55
- Status last verified
- Mar 2022
- First submitted
- 5 May 2015
- Last updated
- 21 Mar 2022
- 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 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rifaximin on Minimal Hepatic Encephalopathy and Small Intestinal Bacterial Overgrowth in Patients With Cirrhosis
- ClinicalTrials.gov ID
- NCT02439307
- Acronym / sponsor ID
- F-CNIC-2013-55
- Keywords
- Rifaximin, Minimal hepatic encephalopathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because of the reconversion of the hospital to care for patients with COVID19. For this reason, it was not possible to continue recruiting and monitoring patients for this clinical study.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 8 May 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.
A total of 46 patients diagnosed with liver cirrhosis will be recruited. All patients will be evaluated with five psychometric tests and critical flicker frequency to diagnosis minimal hepatic encephalopathy (MHE). A breath test sample will be performed in all patients with MHE with 10 g of lactulose to establish the diagnosis of small intestinal bacterial overgrowth (SIBO). Patients diagnosed with EHM and SIBO will be randomized to receive per day 1200 mg of rifaximin (group A) or placebo (group B) for 2 weeks. A complete medical history, nutritional assessment, biochemical studies, and evaluation of quality of life will be performed in all patients included in the study. Besides the initial visit, patients will receive subsequent care 2, 4, 8, 12, and 24 weeks after the beginning of the study.
Detailed description
MHE impairs the quality of life, increases the risk of motor vehicle accidents, and mortality. Currently, there is no consensus on treatment and yet there are few proven treatment options. Among the factors associated with MHE, is the small intestinal bacterial overgrowth (SIBO) present in 38.6% of patients with MHE. Rifaximin is a broad spectrum antimicrobial administered orally, with low risk of inducing bacterial resistance, and has been used in the treatment of MHE. It is unknown if the beneficial effect on MHE is associated with the elimination of SIBO and its efficacy when administered in patients with simultaneous diagnosis of MHE and SIBO was never been evaluated. The aim of our study is to evaluate the effect of rifaximin on MHE and SIBO in patients with cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifaximin | Active comparator | Drug: RifaximinPatients will receive per day 1200 mg of rifaximin |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive a placebo of rifaximin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of cirrhosis of any etiology
- Men and women between 18 and 70 years.
- Patients diagnosed with minimal hepatic encephalopathy and small intestinal bacterial overgrowth
- Right-holders of the Mexican Social Security Institute
- Patients who agree to participate in the study and signed the informed consent
Key exclusion criteria (13 listed)
- Recent history of alcohol abuse and/or drugs (less than 6 weeks).
- Illiterate
- Alcoholic cirrhosis
- History and/or diagnosis of overt hepatic encephalopathy
- Consumption of psychotropic medications (benzodiazepines, antiepileptics)
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 |
|---|---|---|
| RifaximinAlso: Antibiotic1200 mg of rifaximin for 2 weeks. | Drug | Rifaximin |
| PlaceboAlso: Action lacks substancePlacebo for 2 weeks | Drug | Placebo |
Primary outcome
Reversal of small intestinal bacterial overgrowth
Time frame: 2 weeks
Analyze the number of patients who reverts the small intestinal bacterial overgrowth after the study
2 secondary outcomes
Quality of life improvement
Time frame: 2 weeks
Reversal of minimal hepatic encephalopathy
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: The study was terminated because of the reconversion of the hospital to care for patients with COVID19. For this reason, it was not possible to continue recruiting and monitoring patients for this clinical study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- 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.
Segundo Moran principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifaximin in people with Small Intestinal Bacterial Overgrowth and Liver Cirrhosis, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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 5 inclusion and 13 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 21 Mar 2022. 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 Mexico. 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?
The study was stopped early (reason given: The study was terminated because of the reconversion of the hospital to care for patients with COVID19. For this reason, it was not possible to continue recruiting and monitoring patients for this clinical study.). 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?
Reversal of small intestinal bacterial overgrowth (time frame: 2 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 21 Mar 2022.