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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01655121 |
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Date of registration:
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12/07/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of High-protein High-fiber Diet in Patients With Autoimmune Hepatitis
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Scientific title:
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Effect of a High-protein High-fiber Diet and Nutritional Status, Serum Ammonia Concentration and Plasma Cytokines in Patients With Autoimmune Hepatitis |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01655121 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Aldo Torre Delgadillo, M.D. M.Sc |
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Address:
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Telephone:
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Email:
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Affiliation:
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INCMNSZ |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Autoimmune hepatitis (Non cirrhotic)
- Diagnose of Autoimmune hepatitis
- Presence of antinuclear antibody (ANA, SMA)
- Biochemical evidence, based on elevation of transaminases
- Biopsy compatible with Autoimmune hepatitis
- Ambulatory patients
Autoimmune hepatitis (Cirrhotic)
- Presence of antinuclear antibody (ANA, SMA)
- Biochemical evidence, based on elevation of transaminases
- Biopsy compatible with autoimmune cirrhosis
- Hepatic cirrhosis by USD
- Ambulatory patients
- Diagnose of Autoimmune cirrhosis by two or more of the following criteria:
- Albumin <3.4g/dl
- INR>1.2
- Total bilirubin >2mg/dl
- Presence of esophageal varices by endoscopy
Exclusion Criteria:
- Hospitalized patients
- Overlapping syndrome with predominant primary biliary cirrhosis
- Chronic renal failure
- Hepatocellular carcinoma
- Neuropsychiatric disorders
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Autoimmune Hepatitis
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Cirrhosis
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Intervention(s)
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Dietary Supplement: High protein high fiber diet
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Primary Outcome(s)
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Nutritional Status
[Time Frame: Participants will be assessed for six months]
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Secondary Outcome(s)
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Minimal hepatic encephalopathy
[Time Frame: Participants will be assessed for six months]
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Quality of life
[Time Frame: Participants will be assessed for six months]
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Secondary ID(s)
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GAS-501-11/12-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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