Hepatic CirrhosisNCT01135628
Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy
A study testing Auxiliary Treatment, Hyperproteic and fiber-rich diet and Nitazoxanide in people with Hepatic Cirrhosis and Minimal Hepatic Encephalopathy, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
Hepatic encephalopathy is a serious complication of cirrhosis which relays under the burden of diseases with therapeutical difficulties for its given morbidity and mortality and the high recurrence it poses. Its treatment remains a challenge for most of the cases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatic Cirrhosis, Minimal Hepatic Encephalopathy
- What is being tested?
- Auxiliary Treatment, Hyperproteic and fiber-rich diet and Nitazoxanide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2010to Jul 2014
- 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
- Hepatic Cirrhosis
- Minimal hepatic Encephalopathy
Who cannot join
- Personal history of surgery in the last 4 weeks
- Use of neuropsychiatric drugs
- Neuropsychiatric disorders (Schizophrenia, bipolar disorder, major depression, dementia and Attention-deficit hyperactivity disorder)
- Thyroid disorders without replacement therapy
- Hepatic or renal transplant
- Alcoholism with active ingest of alcohol in the last 6 months
Show all 12Show fewer
- Pregnancy
- Labour turn-overs
- Spontaneous bacterial Peritonitis
- Personal history of hepatocellular carcinoma
- Placement of transjugular intrahepatic portosystemic shunt
- Use of a probiotic in the last 6 months
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14000
About this study
Official title: Hyperproteic and Fiber-rich Diet Plus Probiotics (Lactobacillus Reuteri) and Nitazoxanide in the Treatment of Minimal Hepatic Encephalopathy.
Hepatic encephalopathy is a serious complication of cirrhosis which relays under the burden of diseases with therapeutical difficulties for its given morbidity and mortality and the high recurrence it poses. Its treatment remains a challenge for most of the cases. Even more, minimal hepatic encephalopathy is an entity that has an additional morbidity for it being a subclinical entity. As so, the investigators propose an auxiliary treatment for the management of such patients with minimal hepatic encephalopathy, using a specific diet consisting on hyperproteic and fibre-rich foods along with two independent interventions, whether a probiotic, lactobacillus reuteri, or a drug, nitozoxanide, so to diminish the rate of progression to any clinical stage of hepatic encephalopathy and to revert minimal hepatic encephalopathy itself to none hepatic encephalopathy.
- Conditions
- Hepatic Cirrhosis, Minimal Hepatic Encephalopathy
- Being tested
- Auxiliary Treatment, Hyperproteic and fiber-rich diet, Nitazoxanide
- Keywords
- Hepatic cirrhosis, Minimal hepatic encephalopathy, Hyperproteic and fiber-rich diet, Lactobacillus reuteri, Psychometric Hepatic Encephalopathy Score (PHES), Critical Flicker Frequency (CFF)
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auxiliary TreatmentOther
Also called Biogaia, Probiotics
Lactobacillus reuteri, 1 tablet bid, each of 100,000,000 FCU for 6 months
Hyperproteic and fiber-rich dietDietary supplement
Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet
NitazoxanideDrug
Nitazoxanide tablets 400 mg, bid, orally for 6 months
| Study group | Role | What they receive |
|---|---|---|
| MHE and diet plus lactobacillus reuteri | Active comparator | Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and lactobacillus reuteri. Receives: Other: Auxiliary Treatment; Dietary Supplement: Hyperproteic and fiber-rich diet |
| MHE and diet | Active comparator | Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods. Receives: Dietary Supplement: Hyperproteic and fiber-rich diet |
| MHE and diet plus nitazoxanide | Active comparator | Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and nitazoxanide. Receives: Dietary Supplement: Hyperproteic and fiber-rich diet; Drug: Nitazoxanide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reverse minimal hepatic encephalopathy
Reverse minimal hepatic encephalopathy to none evidence of hepatic encephalopathy
Measured: 3 months
Reverse minimal hepatic encephalopathy
Reverse minimal hepatic encephalopathy to none evidence of clinical hepatic encephalopathy
Measured: 6 months
Secondary outcomes (2)
Prevention of progression
Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy.
Measured: 3 months
Prevention of progression
Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Aldo Torre-Delgadillo, MD, Principal investigator, Instituto Nacional de Ciencias Medicas de Nutricion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135628
- Sponsor's protocol ID
- GAS-83-09/10-1
- Status last verified
- Aug 2014
- First submitted
- 26 May 2010
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperproteic and Fiber-rich Diet Plus Probiotics (Lactobacillus Reuteri) and Nitazoxanide in the Treatment of Minimal Hepatic Encephalopathy.
- ClinicalTrials.gov ID
- NCT01135628
- Acronym / sponsor ID
- GAS-83-09/10-1
- Conditions
- Hepatic Cirrhosis, Minimal Hepatic Encephalopathy
- Keywords
- Hepatic cirrhosis, Minimal hepatic encephalopathy, Hyperproteic and fiber-rich diet, Lactobacillus reuteri, Psychometric Hepatic Encephalopathy Score (PHES), Critical Flicker Frequency (CFF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 Jun 2010 (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.
Hepatic encephalopathy is a serious complication of cirrhosis which relays under the burden of diseases with therapeutical difficulties for its given morbidity and mortality and the high recurrence it poses. Its treatment remains a challenge for most of the cases. Even more, minimal hepatic encephalopathy is an entity that has an additional morbidity for it being a subclinical entity. As so, the investigators propose an auxiliary treatment for the management of such patients with minimal hepatic encephalopathy, using a specific diet consisting on hyperproteic and fibre-rich foods along with two independent interventions, whether a probiotic, lactobacillus reuteri, or a drug, nitozoxanide, so to diminish the rate of progression to any clinical stage of hepatic encephalopathy and to revert minimal hepatic encephalopathy itself to none hepatic encephalopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MHE and diet plus lactobacillus reuteri | Active comparator | Other: Auxiliary Treatment, Dietary Supplement: Hyperproteic and fiber-rich dietPatients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and lactobacillus reuteri. |
| MHE and diet | Active comparator | Dietary Supplement: Hyperproteic and fiber-rich dietPatients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods. |
| MHE and diet plus nitazoxanide | Active comparator | Dietary Supplement: Hyperproteic and fiber-rich diet, Drug: NitazoxanidePatients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and nitazoxanide. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hepatic Cirrhosis
- Minimal hepatic Encephalopathy
Key exclusion criteria (12 listed)
- Personal history of surgery in the last 4 weeks
- Use of neuropsychiatric drugs
- Neuropsychiatric disorders (Schizophrenia, bipolar disorder, major depression, dementia and Attention-deficit hyperactivity disorder)
- Thyroid disorders without replacement therapy
- Hepatic or renal transplant
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 |
|---|---|---|
| Auxiliary TreatmentAlso: Biogaia, ProbioticsLactobacillus reuteri, 1 tablet bid, each of 100,000,000 FCU for 6 months | Other | MHE and diet plus lactobacillus reuteri |
| Hyperproteic and fiber-rich dietHyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet | Dietary supplement | MHE and diet, MHE and diet plus lactobacillus reuteri, MHE and diet plus nitazoxanide |
| NitazoxanideNitazoxanide tablets 400 mg, bid, orally for 6 months | Drug | MHE and diet plus nitazoxanide |
Primary outcome
Reverse minimal hepatic encephalopathy
Time frame: 3 months
Reverse minimal hepatic encephalopathy to none evidence of hepatic encephalopathy
Reverse minimal hepatic encephalopathy
Time frame: 6 months
Reverse minimal hepatic encephalopathy to none evidence of clinical hepatic encephalopathy
2 secondary outcomes
Prevention of progression
Time frame: 3 months
Prevention of progression
Time frame: 6 months
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 20 Aug 2014.
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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.
Aldo Torre-Delgadillo, MD principal investigator
Instituto Nacional de Ciencias Medicas de Nutricion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auxiliary Treatment, Hyperproteic and fiber-rich diet and Nitazoxanide in people with Hepatic Cirrhosis and Minimal Hepatic Encephalopathy, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran 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 2 inclusion and 12 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 20 Aug 2014. 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. 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?
Reverse minimal hepatic encephalopathy (time frame: 3 months). 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?
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 20 Aug 2014.