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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)

To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics.

Not Applicable
Conditions
Cirrhosis
Interventions
Drug: PEG- 17 gm sachet
First Posted Date
2018-02-28
Last Posted Date
2018-02-28
Lead Sponsor
Institute of Liver and Biliary Sciences, India
Target Recruit Count
110
Registration Number
NCT03448770
Locations
🇮🇳

Institute of liver and Biliary Sciences, New Delhi, Delhi, India

Efficacy of Dicopeg Junior in Comparison With Lactulose for the Treatment of Functional Constipation in Children Aged 6 Months to 6 Years.

Phase 4
Conditions
Constipation
Interventions
Drug: polyethylene glycols (PEG) 3350
First Posted Date
2017-06-06
Last Posted Date
2017-06-06
Lead Sponsor
Children's Memorial Health Institute, Poland
Target Recruit Count
102
Registration Number
NCT03177434
Locations
🇵🇱

University of Rzeszow, Rzeszow, Poland

🇵🇱

Department of Pediatrics, Gastroenterology and Allergology; Medical University of Bialystok, Bialystok, Poland

🇵🇱

Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics; The Childrens Memorial Health Institute, Warsaw, Poland

To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis.

Not Applicable
Withdrawn
Conditions
Liver Cirrhosis
Interventions
Dietary Supplement: Nutrition
Dietary Supplement: Diet
First Posted Date
2017-05-19
Last Posted Date
2018-12-11
Lead Sponsor
Institute of Liver and Biliary Sciences, India
Registration Number
NCT03161106
Locations
🇮🇳

Institute of Liver and Biliary Sciences, New Delhi, Delhi, India

High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit.

Not Applicable
Withdrawn
Conditions
Refractory Hepatic Encephalopathy
Interventions
Biological: Plasmapheresis
First Posted Date
2017-04-14
Last Posted Date
2019-11-04
Lead Sponsor
Institute of Liver and Biliary Sciences, India
Registration Number
NCT03115697
Locations
🇮🇳

Institute of Liver and Biliary Sciences, New Delhi, Delhi, India

PEG (Polyethylene Glycol)Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy

Phase 4
Conditions
Hepatic Encephalopathy
Interventions
First Posted Date
2017-04-04
Last Posted Date
2017-04-27
Lead Sponsor
Sherief Abd-Elsalam
Target Recruit Count
100
Registration Number
NCT03100513
Locations
🇪🇬

Tropical medicine dept.-Tanta university hospital, Cairo, Egypt

Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy

Phase 2
Conditions
Encephalopathy, Hepatic
Interventions
First Posted Date
2015-06-08
Last Posted Date
2017-08-21
Lead Sponsor
Sherief Abd-Elsalam
Target Recruit Count
120
Registration Number
NCT02464124
Locations
🇪🇬

Tanta university - faculty of medicine, Tanta, Elgharbia, Egypt

Elucidating the Influence of Lactulose Intake on the Gut Microbiota Composition

Not Applicable
Completed
Conditions
Changes in Gut Microbiota Composition After Lactulose Exposure
Interventions
Other: application of sucrose
First Posted Date
2015-03-25
Last Posted Date
2017-07-11
Lead Sponsor
University of Zurich
Target Recruit Count
32
Registration Number
NCT02397512
Locations
🇨🇭

Division of Gastroenterology, University Hospital Zurich, Zurich, Switzerland

The Effects of Nitazoxanide in Hepatic Encephalopathy

Phase 2
Conditions
Hepatic Encephalopathy
Interventions
First Posted Date
2015-01-08
Last Posted Date
2015-01-08
Lead Sponsor
Ain Shams University
Target Recruit Count
36
Registration Number
NCT02334163
Locations
🇪🇬

Faculty of medicine, Ain Shams University, Cairo, Egypt

Effect of Goal Directed Ammonia Lowering Therapy in Acute on Chronic Liver Failure Patients With Hepatic Encephalopathy.

Not Applicable
Completed
Conditions
Acute-On-Chronic Liver Failure
Interventions
First Posted Date
2014-12-22
Last Posted Date
2018-02-08
Lead Sponsor
Institute of Liver and Biliary Sciences, India
Target Recruit Count
73
Registration Number
NCT02321371
Locations
🇮🇳

Institute of Liver & Biliary Sciences, New Delhi, Delhi, India

Anal Dilatation for Infants and Children With Constipation

Not Applicable
Conditions
Constipation
Interventions
First Posted Date
2014-10-03
Last Posted Date
2014-10-03
Lead Sponsor
Tongji Hospital
Target Recruit Count
100
Registration Number
NCT02255747
Locations
🇨🇳

Tongji Hospital, Wuhan, Hubei, China

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