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Lactulose

Generic Name
Lactulose
Brand Names
Constulose, Enulose, Generlac, Kristalose
Drug Type
Small Molecule
Chemical Formula
C12H22O11
CAS Number
4618-18-2
Unique Ingredient Identifier
9XH2P2N8EP
Background

Lactulose is a synthetic disaccharide derivative of lactose that is most commonly used as a laxative agent despite also being formally indicated to serve as an adjunct therapy in treating portal-systemic encephalopathy (PSE). Despite being first synthesized in 1929, investigations regarding its possible use as a laxative for the treatment of chronic constipation did not occur until the 1960s and its first clinical use for treating PSE was not until 1966.

Nevertheless, although lactulose received formal FDA approval in 1977 and has since become a readily available generic and brand-name non-prescription medication listed on the World Health Organization's List of Essential Medicines as one of the most effective and safe medicines employed in a health system, data regarding its optimal place in therapy is often ambiguous.

Especially considering the use of lactulose as a laxative is typically only considered after lifestyle and dietary modifications fail and the fact that lactulose therapy cannot be ethically withheld from patients diagnosed with PSE in a placebo study, the substance may just be one of many options available for treating constipation and its efficacy in managing PSE may never be formally confirmed or refuted via clinical investigation.

Indication

Lactulose is indicated for use as a laxative in the treatment of chronic constipation in adults and geriatric patients.

Additionally, lactulose is also employed as an adjunct to protein restriction and supportive therapy for the prevention and treatment of portal-systemic encephalopathy (PSE), including both the hepatic pre-coma and coma variations. In particular, lactulose solution has been effective at managing PSE resulting from surgical portacaval shunts or from chronic hepatic diseases like cirrhosis.

Moreover, there have also been studies demonstrating the capacity for lactulose to minimize the formation of gallstones and even some investigations regarding the experimental use of the agent in developing novel anticancer agents owing to its ability to bind galactin carbohydrates involved in various tumor progressions .

Associated Conditions
Constipation, Hepatic Encephalopathy (HE)

Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation

Phase 4
Completed
Conditions
Constipation
Interventions
Drug: Polyethylene glycol (PEG)
First Posted Date
2014-08-29
Last Posted Date
2017-09-15
Lead Sponsor
Xian-Janssen Pharmaceutical Ltd.
Target Recruit Count
280
Registration Number
NCT02228616

A New Scoring System Improves Diagnostic Accuracy of Intestinal Dysganglionosis --a Prospective Study

Not Applicable
Conditions
Hirschsprung Disease
Interventions
Behavioral: conservative treatment
First Posted Date
2014-08-15
Last Posted Date
2014-10-28
Lead Sponsor
Tongji Hospital
Target Recruit Count
80
Registration Number
NCT02216994
Locations
🇨🇳

Tongji Hospital, Wuhan, Hubei, China

Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding

Phase 4
Completed
Conditions
Hepatic Encephalopathy
Interventions
First Posted Date
2014-06-06
Last Posted Date
2018-05-22
Lead Sponsor
Hospital General de Mexico
Target Recruit Count
88
Registration Number
NCT02158182
Locations
🇲🇽

Hospital General de Mexico, Mexico City, Mexico

A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure

Phase 3
Withdrawn
Conditions
Hepatic Encephalopathy
Interventions
First Posted Date
2014-03-13
Last Posted Date
2016-03-02
Lead Sponsor
NYU Langone Health
Registration Number
NCT02086825
Locations
🇺🇸

New York University Langone Medical Center, New York, New York, United States

Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)

Not Applicable
Withdrawn
Conditions
Cirrhosis
AMS
Hepatic Encephalopathy
HE
Altered Mental Status
Interventions
First Posted Date
2013-08-15
Last Posted Date
2015-05-12
Lead Sponsor
New York Presbyterian Brooklyn Methodist Hospital
Registration Number
NCT01923376
Locations
🇺🇸

New York Methodist Hospital, Brooklyn, New York, United States

Quality of Life and Nutritional Improvements in Cirrhotic Patients

Phase 4
Terminated
Conditions
Portal Hypertension
Liver Cirrhosis
Hepatic Encephalopathy
Interventions
First Posted Date
2013-04-29
Last Posted Date
2013-09-23
Lead Sponsor
Tampa General Hospital
Target Recruit Count
4
Registration Number
NCT01842113
Locations
🇺🇸

Tampa General Medical Group, Tampa, Florida, United States

The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy

Phase 4
Completed
Conditions
Hepatic Encephalopathy
Cirrhosis
Interventions
First Posted Date
2013-04-29
Last Posted Date
2019-09-09
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
222
Registration Number
NCT01842581
Locations
🇺🇸

The Center for Liver and Biliary Disease, Baltimore, Maryland, United States

🇺🇸

Inland Empire Liver Foundation, Rialto, California, United States

🇺🇸

Asheville Gastroenterology Associates, PA, Asheville, North Carolina, United States

and more 33 locations

Diagnosis of Covert/Minimal Hepatic Encephalopathy by Means of Continuous Reaction Time Measurement

Not Applicable
Completed
Conditions
Liver Cirrhosis
Hepatic Encephalopathy
Interventions
Other: Placebo
Dietary Supplement: Branched Chain amino acids
First Posted Date
2013-01-23
Last Posted Date
2016-02-23
Lead Sponsor
Mette Munk Lauridsen
Target Recruit Count
136
Registration Number
NCT01773538
Locations
🇩🇰

Odense University Hospital, Odense, Denmark

🇩🇰

Hospital of South West Jutland, Esbjerg, Denmark

Intestinal Permeability in Preterm Infants

Phase 1
Completed
Conditions
Intestinal Permeability
Prematurity
Interventions
First Posted Date
2012-12-24
Last Posted Date
2023-11-18
Lead Sponsor
University of Maryland, Baltimore
Target Recruit Count
211
Registration Number
NCT01756040
Locations
🇺🇸

University of Maryland Medical Center, Baltimore, Maryland, United States

Safety, Efficacy, and Patient Preference of Split-Dose Crystalline Lactulose as a Preparation for Colonoscopy in Adults

Phase 2
Completed
Conditions
Colonoscopy
Interventions
First Posted Date
2012-07-26
Last Posted Date
2014-08-08
Lead Sponsor
Benaroya Research Institute
Target Recruit Count
40
Registration Number
NCT01650870
Locations
🇺🇸

Virginia Mason Medical Center, Seattle, Washington, United States

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