Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy

2014-07-23 21:09:23 | BioPortfolio


Introduction: Mortality due to chronic liver disease is among the first five causes of mortality related to digestive tract and liver diseases in patients on productive age. One of the most frequent complications of chronic liver insufficiency is minimal hepatic encephalopathy (MHE), which affects the quality of life and predisposes to the development of clinical hepatic encephalopathy. There are few evidences on the therapeutic alternatives for minimal hepatic encephalopathy. The administration of non-absorbable disaccharides has been proven to ameliorate MHE. Lactose maldigestion may justify the use of lactose in patients with chronic liver disease as a non-absorbable disaccharide for the treatment of MHE.

Objective: to evaluate the efficacy of lactose administration in patients with minimal hepatic encephalopathy.

Methodology: Double-blind, randomized, controlled clinical trial. Setting: Patients from the Gastroenterology Research Laboratory at "Centro Médico Nacional Siglo XXI" (IMSS) Mexico City with diagnosis of chronic liver disease of whichever etiology, minimal hepatic encephalopathy and lactose maldigestion.

Intervention: Two groups of patients with MHE will be studied. The treatment group (n=17) will receive whole milk (24 g lactose) and the control group (n=17) will receive "lactose-free" milk (3.5 g of lactose) two times a day for 21 days. Clinical history, nutritional assessment, biochemical studies, psychometric tests and a quality of life questionnaire will be performed. The patient will be assessed weekly 21 days.

Study variables: minimal hepatic encephalopathy, quality of life and blood ammonium.

Randomization: An external monitor will control the randomization process in order to allocate the patients into both study group and will not share the assignation codes with anyone until the end of the study.

Double blind: the researchers and patients will not have information on the assignation of treatment.

Ethical precepts: The study protocol was designed according to the CONSORT (Consolidated Standards of Reporting Trials) and was approved by the IMSS´s National Commission of Scientific Research. The informed consent will be written in accordance to the Declaration of Helsinki, the dispositions of the Health Secretariat in Human Research and the requirements of the Ethics Commission.

Interest conflict: none

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Hepatic Encephalopathy


whole milk vs lactose-free milk


Instituto Mexicano del Seguro Social
Distrito Federal


Not yet recruiting


Coordinación de Investigación en Salud, Mexico

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:09:23-0400

Clinical Trials [1312 Associated Clinical Trials listed on BioPortfolio]

Whole Milk Intake and Cardio-metabolic Risk Factors

Milk is the source of high-quality protein, calcium, and other vitamins and minerals. Epidemiologic studies have linked high consumption of milk with risk of metabolic syndrome, T2DM, hype...

Incidence of Lactose Intolerance Among Self-reported Lactose Intolerant People

This is a 3-sites, double-blinded, randomized, 2X2 cross-over study aiming to compare effects of milk containing only A2 type beta casein versus milk containing both A1 and A2 beta casein ...

Efficacy of L-Ornithine-L-Aspartate in Acute Hepatic Encephalopathy

Hepatic encephalopathy is caused by the effects on the brain of substances that under normal circumstances are efficiently metabolized in the liver. The hyperammonemia is the main factor r...

Comparing the Digestion of Milk With Different Beta-casein Protein Content by Dairy Intolerant Persons

Persons with dairy intolerance may experience cramps/abdominal pain, bloating, flatulence, acute diarrhea, or fecal urgency when they ingest excessive amounts of lactose. The intensity of ...

HYBRID: Hydrogen Breath Test in Lactose Digestion

The purpose of this study is to investigate the effect of a fermented infant formula on lactose digestion in lactose intolerant adults.

PubMed Articles [7508 Associated PubMed Articles listed on BioPortfolio]

(SMPRs®) 2018.009: Lactose in Low-Lactose or Lactose-Free Milk, Milk Products, and Products Containing Dairy Ingredients.

A pilot study on nutrients, antimicrobial proteins, and bacteria in commerce-free models for exchanging expressed human milk in the USA.

Expressed human milk can be donated or sold through a variety of channels, including human milk banks, corporations or individuals, or peer-to-peer milk sharing. There is a paucity of research regardi...

A squaramide-based metal-organic framework as a luminescent sensor for the detection of lactose in aqueous solution and in milk.

A novel squaramide-containing metal-organic framework (MOF) has been designed and synthesized, which represents the first example of the luminescence selective detection of lactose over other monosacc...


The objective of this study was to determine the major nutrient composition of Indian rhinoceros milk ( Rhinoceros unicornis) over the first 13 mo of an 18-mo lactation period and to compare the resul...

Evaluation of a Standardized Bakery Product (SUTMEK) as a Potential Tool for Baked-Milk Tolerance and Immunotherapy Research Studies.

About 65-80% of children with IgE-mediated cow's milk allergy (CMA) can tolerate extensively heated milk. We have invested in the mass fabrication of a test product containing milk protein baked at 18...

Medical and Biotech [MESH] Definitions

Allergic reaction to milk (usually cow's milk) or milk products. MILK HYPERSENSITIVITY should be differentiated from LACTOSE INTOLERANCE, an intolerance to milk as a result of congenital deficiency of lactase.

The condition resulting from the absence or deficiency of LACTASE in the MUCOSA cells of the GASTROINTESTINAL TRACT, and the inability to break down LACTOSE in milk for ABSORPTION. Bacterial fermentation of the unabsorbed lactose leads to symptoms that range from a mild indigestion (DYSPEPSIA) to severe DIARRHEA. Lactose intolerance may be an inborn error or acquired.

The processes of milk secretion by the maternal MAMMARY GLANDS after PARTURITION. The proliferation of the mammary glandular tissue, milk synthesis, and milk expulsion or let down are regulated by the interactions of several hormones including ESTRADIOL; PROGESTERONE; PROLACTIN; and OXYTOCIN.

Expulsion of milk from the mammary alveolar lumen, which is surrounded by a layer of milk-secreting EPITHELIAL CELLS and a network of myoepithelial cells. Contraction of the myoepithelial cells is regulated by neuroendocrine signals.

The major protein constituents of milk are CASEINS and whey proteins such as LACTALBUMIN and LACTOGLOBULINS. IMMUNOGLOBULINS occur in high concentrations in COLOSTRUM and in relatively lower concentrations in milk. (Singleton and Sainsbury, Dictionary of Microbiology and Molecular Biology, 2d ed, p554)

More From BioPortfolio on "Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy"

Quick Search


Relevant Topics

Hepatology is the study of liver, gallbladder, biliary tree, and pancreas, and diseases associated with them. This includes viral hepatitis, alcohol damage, cirrhosis and cancer. As modern lifestyles change, with alcoholism and cancer becoming more promi...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Astroesophageal Reflux Disease (GERD) Barrett's Esophagus Celiac Disease Cholesterol Crohn's Disease Gastroenterology Hepatitis Hepatology Irritable Bowel Syndrome (IBS) Pancreatitis Peptic Ulcer Disease...

Searches Linking to this Trial