The aim of this study is to investigate the effects of lactulose to decrease liver size in non-alcoholic fatty liver disease. Forty patients will be randomly assigned into intervention and control groups, each containing 20 subjects. Before and after end of the study will be measured liver size, liver enzymes levels and probiotic bacteria colony count of 2 grams of stool. Inclusion criteria: non-alcoholic fatty liver disease; age between 30 and 70 years. Exclusion criteria: antibiotic usage; presence of acute and chronic gastrointestinal diseases leading to intestinal dysfunction; use of medications affecting bowel function.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010715879N3
Registration date:2015-02-08, 1393/11/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-02-08, 1393/11/19
Registrant information
Name
Reza Ghotaslou
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4661
Email address
gottasloreza@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-02-18, 1393/11/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of lactulose effects in the treatment of non alcoholic fatty liver disease in comparison with vitamin E: A randomized, clinical trial
Public title
Lactulose effect in non alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Non alcoholic fatty liver disease, age between 30 and 70 years. Exclusion criteria: Diabetic mellitus, viral hepatitis, congenital hepatitis, drug hepatitis, autoimmune hepatitis, alcohol use, blood triglyceride more than 500mg, inflammatory bowel diseases ( Ulcerative colitis or Crohn's disease), chronic diarrhea, antibiotic use, contraindication of lactolus use, use of medications affecting bowel function, and consent to participate in the study.
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients will be randomly divided into two groups using the software Randlist 1.2.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
Central building II ,Third floor, Golgasht Street, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2014-07-20, 1393/04/29
Ethics committee reference number
9361
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Non alcoholic fatty liver disease
Primary outcomes
1
Description
Liver size
Timepoint
Baseline and one month after starting the study.
Method of measurement
Ultrasound sonography
Secondary outcomes
1
Description
Intestinal probiotic count
Timepoint
Baseline and one month after starting the study.
Method of measurement
Pour plate technique
2
Description
Drug complications
Timepoint
One month after starting the study.
Method of measurement
Ask the patient
Intervention groups
1
Description
Patients in the intervention group receive 20- 30cc lactulose daily for one month. Lactulose syrup (or Laxilose®, 10 g lactulose/15 mL, Alborzdaru) is a synthetic sugar used to treat constipation. In the colon, lactulose is metabolized primarily to lactic acid by bacteria that pull water out from the body and into the colon. Lactulose is also used to reduce the amount of ammonia in the blood of patients with liver disease. Lactulose poorly absorbed from the GI tract when given oral. Side effects of drug are diarrhea, gas, nausea, stomach pain or cramps and vomiting.
Category
Treatment - Drugs
2
Description
The intervention 2: Patients in control group receive vitamin E.