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A Nutritional Approach to Minimal Hepatic Encephalopathy

T

Tel Aviv Sourasky Medical Center

Status

Unknown

Conditions

Minimal Hepatic Encephalopathy

Treatments

Other: Nutritional Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT01083446
0236-08-TLV
TASMC-08-NV-236

Details and patient eligibility

About

This trial will study a possible effect of standard Israeli breakfast (30% of caloric value and 21 gram protein) on cognitive and executive functions (working memory, visual memory, concentration and coordination), on patients with mild-moderate liver cirrhosis.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All consented adults (age > 18), with the diagnosis of CHILD A cirrhosis with MELD score of < 10.
  • Diagnosis of liver cirrhosis as documented by liver biopsy (stage IV) and / or fibroscan (score > 12 kpa) and / or fibrotest (score > 0.74) and /or imaging.

Exclusion criteria

  • History of > grade II hepatic encephalopathy (HE).
  • Diagnosis of dementia, Parkinson disease, Schizophrenia (Patients with major depression will be noted but not excluded).
  • Use of sedatives, tranquilizers or anti- psychotic medication during and/or 2 weeks prior to enrolling Use of antibiotics for any length of period during and/or 2 weeks prior to enrolling.
  • Current use of lactulose or neomycin.
  • Use of alcohol or elicit drugs during and/ or 6 months prior to enrolling.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

A
Active Comparator group
Description:
Nutritional intervention, standard Israeli breakfast
Treatment:
Other: Nutritional Intervention
Other: Nutritional Intervention
B
Active Comparator group
Description:
Nutritional Intervention, fast
Treatment:
Other: Nutritional Intervention
Other: Nutritional Intervention

Trial contacts and locations

1

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Central trial contact

Nachum Vaisman, Prof'

Data sourced from clinicaltrials.gov

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