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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)

Movicol in Childhood Constipation (ProMotion Study)

Phase 2
Completed
Conditions
Chronic Constipation
First Posted Date
2006-11-27
Last Posted Date
2006-11-28
Lead Sponsor
Norgine
Target Recruit Count
60
Registration Number
NCT00404040
Locations
🇬🇧

St Richard's Hospital, Royal West Sussex Hospital NHS Trust, Chichester, United Kingdom

Effect of Lactulose on Minimal Hepatic Encephalopathy and Health-Related Quality of Life

Phase 4
Completed
Conditions
Minimal Hepatic Encephalopathy
Hepatic Encephalopathy
First Posted Date
2006-09-13
Last Posted Date
2007-03-02
Lead Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Target Recruit Count
80
Registration Number
NCT00375375
Locations
🇮🇳

Postgraduate Institute of Medical Education and Research, Chandigarh, UT, India

RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial

Phase 3
Terminated
Conditions
Hepatic Encephalopathy
Interventions
First Posted Date
2006-08-16
Last Posted Date
2019-09-17
Lead Sponsor
University of Miami
Target Recruit Count
13
Registration Number
NCT00364689
Locations
🇺🇸

Center For Liver Diseases - University of Miami, Miami, Florida, United States

Lactulose for the Prevention of Nosocomial Infections in Children

Not Applicable
Conditions
Nosocomial Infection
First Posted Date
2006-01-10
Last Posted Date
2008-02-06
Lead Sponsor
Bnai Zion Medical Center
Target Recruit Count
100
Registration Number
NCT00273949
Locations
🇮🇱

Pediatric Department, Bnai Zion Medical Center, Haifa, Israel

To Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.

Phase 3
Completed
Conditions
Chronic Constipation
Interventions
First Posted Date
2005-11-18
Last Posted Date
2020-04-24
Lead Sponsor
Ipsen
Target Recruit Count
88
Registration Number
NCT00255372
Locations
🇹🇭

Ramathibodi Hospital, Mahidol University,, Bangkok, Thailand

🇹🇭

Maharat Nakhon Ratchasima Hospital, Nakhon Ratchasima, Thailand

Trial to Evaluate Effect of Lactulose on Hard Stools in Patients With Hemorrhoids or Anal Fissures

Phase 4
Terminated
Conditions
Hemorrhoids
Anal Fissures
Interventions
Drug: Plantago ovata
First Posted Date
2005-09-12
Last Posted Date
2008-05-06
Lead Sponsor
Solvay Pharmaceuticals
Target Recruit Count
97
Registration Number
NCT00160290
Locations
🇪🇸

Site 6, Granada, Spain

🇪🇸

Site 2, Barcelona, Spain

🇪🇸

Site 5, Huesca, Spain

and more 5 locations

Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis

Phase 2
Completed
Conditions
Portal Hypertension
Hepatic Encephalopathy
Cirrhosis
First Posted Date
2000-02-25
Last Posted Date
2005-06-24
Lead Sponsor
National Center for Research Resources (NCRR)
Target Recruit Count
16
Registration Number
NCT00004796
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