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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| MHE and diet | Active Comparator | Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods. |
|
| MHE and diet plus nitazoxanide | Active Comparator | Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and nitazoxanide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auxiliary Treatment | Other | Lactobacillus reuteri, 1 tablet bid, each of 100,000,000 FCU for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reverse minimal hepatic encephalopathy | Reverse minimal hepatic encephalopathy to none evidence of hepatic encephalopathy | 3 months |
| Reverse minimal hepatic encephalopathy | Reverse minimal hepatic encephalopathy to none evidence of clinical hepatic encephalopathy | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of progression | Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy. | 3 months |
| Prevention of progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aldo Torre-Delgadillo, MD | Instituto Nacional de Ciencias Medicas de Nutricion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Mexico City | Mexico City | 14000 | Mexico |
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| Hyperproteic and fiber-rich diet | Dietary Supplement | Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet |
|
| Nitazoxanide | Drug | Nitazoxanide tablets 400 mg, bid, orally for 6 months |
|
Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy
| 6 months |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| C041747 | nitazoxanide |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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