High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis

• Register: ClinicalTrials.gov
• Last refreshed on: 20 June 2016
• Main ID: NCT01603199
• Date of registration: 17/05/2012
• Prospective Registration: No
• Primary sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Public title: High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis
• Scientific title: Impact of a High-protein High-fiber Diet on the Nutritional Status of Patients With Primary Biliary Cirrhosis
• Date of first enrolment: September 2011
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01603199
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
• Phase: N/A

Countries of recruitment

Mexico

Contacts

• Name: Aldo Torre Delgadillo, M.D. M.Sc
• Affiliation: INCMNSZ

Key inclusion & exclusion criteria

Inclusion Criteria:

- Controls

Diagnose of primary biliary cirrhosis:

- Biochemical evidence of cholestasis: based mainly on alkaline phosphatase elevation

- Presence of antimitochondrial antibodies (AMA)

- Histologic evidence of nonsuppurative destructive cholangitis and destruction of
interlobular bile ducts.

Ambulatory patients

- Cases

Diagnose of primary biliary cirrhosis:

- Biochemical evidence of cholestasis: based mainly on alkaline phosphatase elevation

- Presence of antimitochondrial antibodies (AMA)

- Histologic evidence of nonsuppurative destructive cholangitis and destruction of
interlobular bile ducts.

Diagnose of liver cirrhosis by two or more of the following criteria:

- Albumin < 3.4 g/dL

- INR = 1.3

- Total bilirubin = 2 mg/dL

- Portal hypertension (esophageal varices, splenomegaly, ascites, etc.)

- Liver biopsy Ambulatory patients

Exclusion Criteria:

- Overlapping syndrome with predominant autoimmune hepatitis

- Hospitalized patients

- Acute or chronic renal failure

- Hepatocellular carcinoma

- Pregnancy

- Neuropsychiatric disorders (Schizophrenia, bipolar disorder, dementia and
attention-deficit hyperactivity disorder)



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Primary Biliary Cirrhosis

Intervention(s)

Dietary Supplement: High protein high fiber diet

Primary Outcome(s)

Nutritional status [Time Frame: Participants will be followed for 6 months]

Secondary Outcome(s)

Quality of life [Time Frame: Participants will be followed for 6 months]

Minimal hepatic encephalopathy [Time Frame: Participants will be followed for 6 months]

Secondary ID(s)

GAS-460-11/12-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors