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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)

A Trial to Improve Quality of Life in People With Cirrhosis

Phase 2
Completed
Conditions
Cirrhosis
Interventions
First Posted Date
2021-09-30
Last Posted Date
2023-11-21
Lead Sponsor
University of Michigan
Target Recruit Count
56
Registration Number
NCT05061992
Locations
🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation

Not Applicable
Conditions
Colon Disease
Interventions
Drug: Polyethylene Glycol (PEG)
First Posted Date
2021-03-11
Last Posted Date
2021-03-11
Lead Sponsor
First People's Hospital of Hangzhou
Target Recruit Count
800
Registration Number
NCT04794049

Efficacy and Safety of E.Coli Nissle 1917 in Patients With Mild (Stage 1-2) or Minimal Hepatic Encephalopathy

Not Applicable
Completed
Conditions
Hepatic Encephalopathy
Liver Cirrhosis
End Stage Liver DIsease
Interventions
Dietary Supplement: E.coli Nissle 1917
First Posted Date
2021-03-08
Last Posted Date
2021-03-08
Lead Sponsor
Bogomolets National Medical University
Target Recruit Count
42
Registration Number
NCT04787276

Polyethylene Glycol Versus Lactulose on Hepatic Encephalopathy in Patients With Cirrhosis;(PEGHE Trial)

Phase 4
Recruiting
Conditions
Hepatic Encephalopathy
Interventions
Drug: Polyethylene Glycols
First Posted Date
2020-06-18
Last Posted Date
2023-04-19
Lead Sponsor
Aga Khan University
Target Recruit Count
102
Registration Number
NCT04436601
Locations
🇵🇰

Aga Khan University, Karachi, Sindh, Pakistan

Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF

Phase 1
Completed
Conditions
Hepatic Encephalopathy
Acute-On-Chronic Liver Failure
Interventions
Drug: Branched chain amino acid
First Posted Date
2020-01-23
Last Posted Date
2022-08-16
Lead Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Target Recruit Count
70
Registration Number
NCT04238416
Locations
🇮🇳

PGIMER, Chandigarh, India

Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose

Phase 4
Recruiting
Conditions
Hepatic Encephalopathy
Pathological Processes
Cirrhosis, Liver
Portal Hypertension
Liver Diseases
Interventions
First Posted Date
2019-08-29
Last Posted Date
2025-01-28
Lead Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Target Recruit Count
238
Registration Number
NCT04073290
Locations
🇳🇱

University Medical Center Groningen, Groningen, Netherlands

🇳🇱

Leiden University Medical Center, Leiden, Netherlands

🇧🇪

Universitaire Ziekenhuizen Leuven, Leuven, Belgium

and more 3 locations

PEG3350 in ACLF With Hepatic Encephalopathy

Phase 4
Conditions
Acute-On-Chronic Liver Failure
Hepatic Encephalopathy
Interventions
Drug: PEG-3350 with Electolytes
First Posted Date
2019-06-17
Last Posted Date
2019-06-17
Lead Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Target Recruit Count
60
Registration Number
NCT03987893
Locations
🇮🇳

Postgraduate Institute of Medical Education and Research, Chandigarh, India

Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

Phase 3
Conditions
Constipation - Functional
Interventions
First Posted Date
2019-05-21
Last Posted Date
2020-10-20
Lead Sponsor
Fakultas Kedokteran Universitas Indonesia
Target Recruit Count
184
Registration Number
NCT03957668
Locations
🇮🇩

Puskesmas Kelurahan Paseban, Jakarta, DKI Jakarta, Indonesia

🇮🇩

Puskesmas Kelurahan Petamburan, Jakarta, DKI Jakarta, Indonesia

🇮🇩

RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital), Jakarta, DKI Jakarta, Indonesia

Mode of Action of Ondansetron, a 5-HT Receptor 3 Antagonist, in Lactulose Induced Diarrhoea

Phase 4
Completed
Conditions
Motility Disorder of Intestine
Ondansetron
Small Bowel Water
Interventions
Diagnostic Test: abdominal MRI
Drug: Placebo oral capsule
First Posted Date
2019-02-07
Last Posted Date
2019-11-27
Lead Sponsor
University of Nottingham
Target Recruit Count
16
Registration Number
NCT03833999
Locations
🇬🇧

University of Nottingham, Nottingham, Nottinghamshire, United Kingdom

Blood Glucose Response After Oral Intake of Lactulose in Mildly Constipated Patients With Diabetes Mellitus Type 2

First Posted Date
2018-09-12
Last Posted Date
2019-04-12
Lead Sponsor
Fresenius Kabi
Target Recruit Count
24
Registration Number
NCT03666546
Locations
🇦🇹

Clinical Research Center (CRC), Graz, Austria

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