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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)

Effectiveness of Oral Lactulose Versus Lactulose Enema in Hepatic Encephalopathy

Phase 4
Not yet recruiting
Conditions
Chronic Liver Disease
Hepatic Encephalopathy
Interventions
First Posted Date
2023-03-29
Last Posted Date
2023-04-05
Lead Sponsor
Khyber Medical College, Peshawar
Target Recruit Count
100
Registration Number
NCT05788627

Efficacy and Safety of Nifuroxazide in the Treatment of Hepatic Encephalopathy in Egyptian Patients With Liver Cirrhosis

Phase 3
Recruiting
Conditions
Hepatic Encephalopathy
Interventions
First Posted Date
2023-03-06
Last Posted Date
2025-05-14
Lead Sponsor
Cairo University
Target Recruit Count
102
Registration Number
NCT05754996
Locations
🇪🇬

National Hepatology and Tropical Medicine Research Institute (NHTMRI), Cairo, Egypt

Lactulose vs. Polyethylene Glycol as Bowel Preparation for Colonoscopy in Adults

Not Applicable
Completed
Conditions
Polyethylene Glycol
Lactulose
Bowel Preparation
Colonoscopy
Bisacodyl
Interventions
First Posted Date
2023-02-13
Last Posted Date
2023-12-27
Lead Sponsor
Hospital de Clínicas Dr. Manuel Quintela
Target Recruit Count
150
Registration Number
NCT05726344
Locations
🇺🇾

Hospital de Clinicas, Montevideo, Uruguay

Intravenous BCAA for HE in ACLF (BCAA-HE-ACLF)

Phase 1
Recruiting
Conditions
Hepatic Encephalopathy
Acute-On-Chronic Liver Failure
Interventions
Drug: Branch Chain Amino Acid
First Posted Date
2023-01-26
Last Posted Date
2024-04-24
Lead Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Target Recruit Count
226
Registration Number
NCT05700695
Locations
🇮🇳

Dr. Madhumita Premkumar, Chandigarh, India

Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation in Low-risk Patients

Not Applicable
Completed
Conditions
Colonic Neoplasms
Interventions
First Posted Date
2022-12-13
Last Posted Date
2022-12-13
Lead Sponsor
Zhang Xiaofeng,MD
Target Recruit Count
255
Registration Number
NCT05648318
Locations
🇨🇳

Hangzhou first people's Hospital, Hangzhou, Zhejiang, China

Efficacy of Polyethylene Glycol vs Lactulose With Isabgol in Acute Fissure-in-Ano: PEGASIS Trial

Phase 2
Completed
Conditions
Anal Fissure
Constipation
Interventions
First Posted Date
2022-04-22
Last Posted Date
2023-07-25
Lead Sponsor
All India Institute of Medical Sciences, Bhubaneswar
Target Recruit Count
144
Registration Number
NCT05341180
Locations
🇮🇳

All India Institute of Medical Sciences, Bhubaneswar, Odisha, India

Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhotic Patients

Early Phase 1
Conditions
Hepatic Encephalopathy
Interventions
First Posted Date
2022-03-15
Last Posted Date
2022-03-15
Lead Sponsor
Madonna Magdy Fahmy
Target Recruit Count
316
Registration Number
NCT05279586

Lubiprostone for Functional Constipation in the Under 18 Years Patients

Phase 3
Completed
Conditions
Clinical Efficacy
Treatment Efficacy
Drug Side Effect
Interventions
First Posted Date
2021-12-03
Last Posted Date
2022-11-15
Lead Sponsor
Alexandria University
Target Recruit Count
274
Registration Number
NCT05144295
Locations
🇪🇬

Faculty of Medicine, Alexandria, Egypt

🇪🇬

Alexandria Main University Hospital, Alexandria, Egypt

Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Phase 4
Conditions
Constipation-predominant Irritable Bowel Syndrome
Functional Dyspepsia
Interventions
First Posted Date
2021-11-26
Last Posted Date
2021-12-13
Lead Sponsor
RenJi Hospital
Target Recruit Count
78
Registration Number
NCT05134584
Locations
🇨🇳

RenJiH, Shanghai, Shanghai, China

Effect of Lactulose and/or Polyethylene Glycol Solution for Bowel Preparation for Colonscopy Procedures

Phase 3
Completed
Conditions
Colonoscopy
Interventions
First Posted Date
2021-10-13
Last Posted Date
2023-01-03
Lead Sponsor
Sichuan University
Target Recruit Count
200
Registration Number
NCT05076799
Locations
🇨🇳

west china fourth hospital of Sichuan university, Chendu, Sichuan, China

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