Clinical trial NCT01655121: Effect of High-protein High-fiber Diet in Patients With Autoimmune Hepatitis
Official title: Effect of a High-protein High-fiber Diet and Nutritional Status, Serum Ammonia Concentration and Plasma Cytokines in Patients With Autoimmune Hepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autoimmune Hepatitis
Cirrhosis
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2012-08-01
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Autoimmune hepatitis is a chronic disease of the liver caused by an alteration of the immune response that attacks the body's own hepatocytes, progressively, leading to cirrhosis and liver failure.

There are few studies on dietary management in hepatitis and most of theme have focused on micronutrients specifically vitamin D to prevent osteoporosis, and decreased symptoms of other diseases associated, but few recommendations have been made regarding a complete dietary approach. Fiber has been proven to increase the excretion of nitrogen products and consequently reduce its blood levels and an adequate protein intake (1.2g/kg) has shown to decrease endogenous catabolism in cirrhotics patients.

The implementation of a high protein high fiber nutrition plan and improves nutritional status of patients with autoimmune cirrhosis.

Detailed description: Each participant will receive a high protein (1.2g/kg/day) and high fiber (30g/day) dietary plan. The monitoring of adherence to the diet will be once a month for the duration of the study period.

There will be an nutritional assessment by anthropometric techniques: arm circumference, triceps skinfold, weight, height and body mass index as parameters of malnutrition by taking the standard for cirrhotic patients. Body composition was measured by bioelectric impedance to obtain fat mass, lean and total fluid content.

The presence of minimal hepatic encephalopathy will be assessed by PHES and CFF and applied three times during the study and the quality of life questionnaire SF-36 CLDQ and will be held in direct interview at the first visit and at study end.

Were also measured serum concentrations of ammonium, TNF-alpha, IL-1, IL-6, IL-10, renin, angiotensin and aldosterone.

Eligibility criteria: 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

Primary outcomes:
measure: Nutritional Status
timeFrame: Participants will be assessed for six months
Secondary outcomes:
measure: Minimal hepatic encephalopathy
timeFrame: Participants will be assessed for six months
measure: Quality of life
timeFrame: Participants will be assessed for six months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
state: D.f.
Study officials:
affiliation: INCMNSZ
name: Aldo Torre Delgadillo, M.D. M.Sc
role: PRINCIPAL_INVESTIGATOR
References: