MedPath

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 Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis

Phase 2
Recruiting
Conditions
Candidal Vulvovaginitis (ICD-10 Code: B37.3)
Vulvovaginal Candidiasis (VVC)
Interventions
Drug: Clotrimazole+Lactulose.
Drug: Canesten (Clotrimazole)
First Posted Date
2025-02-19
Last Posted Date
2025-02-19
Lead Sponsor
AVVA Pharmaceuticals Ltd.
Target Recruit Count
264
Registration Number
NCT06835361
Locations
🇧🇾

Healthcare Institution "1st Central District Polyclinic of the Central District of Minsk", Minsk, Belarus

🇧🇾

Healthcare Institution "14th Central District Polyclinic of the Partizansky District of Minsk", Minsk, Belarus

🇧🇾

Healthcare Institution "2nd Central District Polyclinic of the Frunzensky District of Minsk", Minsk, Belarus

and more 4 locations

Goal Directed Ammonia Lowering Therapy in Hyperammonemic ACLF Patients With no Overt HE to Reduce Major Adverse Liver Related Outcomes (GOAL Trial)

Not Applicable
Not yet recruiting
Conditions
Acute on Chronic Liver Failure
Interventions
Other: Standard Medical treatment
First Posted Date
2025-02-04
Last Posted Date
2025-02-04
Lead Sponsor
Institute of Liver and Biliary Sciences, India
Target Recruit Count
90
Registration Number
NCT06808009
Locations
🇮🇳

Institute of Liver & Biliary Sciences (ILBS), New Delhi, Delhi, India

Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for Colonoscopy

Phase 4
Conditions
Lactulose
Bowel Preparation
Interventions
Drug: polyethylene glycol (PEG)
First Posted Date
2024-12-27
Last Posted Date
2024-12-27
Lead Sponsor
Haifeng Lan
Target Recruit Count
444
Registration Number
NCT06748638
Locations
🇨🇳

Jinling Hospital, China, Nanjing, Jiangsu, China

Effect of Agave Inulin on Constipation and Quality of Life in Peritoneal Dialysis Patients.

Not Applicable
Conditions
Constipation
Peritoneal Dialysis (PD)
CKD
Quality of Life (QOL)
Interventions
Dietary Supplement: inulin
First Posted Date
2024-12-17
Last Posted Date
2024-12-17
Lead Sponsor
NIN Institute
Target Recruit Count
45
Registration Number
NCT06738550
Locations
🇲🇽

Centro Medico ISSEMyM, Toluca, Metepec, Estado de Mexico, Mexico

BCAA Vs. Rifaximin in Patients with Cirrhosis for Secondary Prophylaxis of HE

Not Applicable
Recruiting
Conditions
Hepatic Encephalopathy
Decompensated Cirrhosis
Minimal Hepatic Encephalopathy
Interventions
Drug: Oral Branched chain Amino acid
Drug: Placebo for BCAA
First Posted Date
2024-08-05
Last Posted Date
2025-02-14
Lead Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Target Recruit Count
336
Registration Number
NCT06538077
Locations
🇮🇳

PGIMER, Chandigarh, India

Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)

Not Applicable
Not yet recruiting
Conditions
Overt Hepatic Encephalopathy
Interventions
Drug: Human albumin infusion at a modified dosage
Drug: Human albumin infusion at a routine dosage
Drug: Branched-Chain Amino Acids
First Posted Date
2024-07-03
Last Posted Date
2025-03-04
Lead Sponsor
General Hospital of Shenyang Military Region
Target Recruit Count
174
Registration Number
NCT06483737
Locations
🇨🇳

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area), Shenyang, Liaoning, China

Efficacy and Safety of Natamycin and Lactulose Vaginal Suppositories in Treatment of Vulvovaginal Candidiasis

Phase 3
Completed
Conditions
Vulvovaginal Candidiasis, Genital
Interventions
Combination Product: Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories
Drug: Pimafucin® (natamycin) 100 mg vaginal suppositories
First Posted Date
2024-05-13
Last Posted Date
2024-05-13
Lead Sponsor
Avva Rus, JSC
Target Recruit Count
218
Registration Number
NCT06411314
Locations
🇷🇺

Department of Reproductive Medicine and Surgery at the A.I. Evdokimov Moscow State Medical and Dental University, Moscow, Russian Federation

Assesment of Lactulose vs Lactobacillus Acidophilus Effect in CKD Patients

Not yet recruiting
Conditions
CKD
First Posted Date
2023-07-07
Last Posted Date
2023-07-07
Lead Sponsor
Assiut University
Target Recruit Count
150
Registration Number
NCT05934552

Efficacy of L-Ornithine L-Aspartate and Polyethylene Glycol in Cirrhotic Patients With Overt Hepatic Encephalopathy

Phase 4
Not yet recruiting
Conditions
Hepatic Encephalopathy Stage 2
Hepatic Encephalopathy Stage 3
Hepatic Encephalopathy Stage 4
Interventions
First Posted Date
2023-06-27
Last Posted Date
2023-07-13
Lead Sponsor
Jinnah Postgraduate Medical Centre
Target Recruit Count
360
Registration Number
NCT05920213
Locations
🇵🇰

Nishtar Medical Univeristy and Hospital, Multan, Punjab, Pakistan

🇵🇰

Medical ICU, Jinnah Postgraduate Medical Centre, Karachi, Sindh, Pakistan

🇵🇰

Sheikh Zayed Medical College/Hospital, Rahim Yar Khan, Punjab, Pakistan

and more 3 locations

LiveSMART Trial to Prevent Falls in Patients With Cirrhosis

Phase 3
Recruiting
Conditions
Cirrhosis, Liver
Portal Hypertension
Interventions
Behavioral: Enhanced Usual Care
Behavioral: Investigator recommended exercise
Behavioral: TeleTai-Chi (virtual)
First Posted Date
2023-04-03
Last Posted Date
2025-05-07
Lead Sponsor
University of Michigan
Target Recruit Count
430
Registration Number
NCT05794555
Locations
🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

🇺🇸

University of Pennsylvania, Philadelphia, Pennsylvania, United States

🇺🇸

Baylor Scott & White Research Institute (BSW), Dallas, Texas, United States

© Copyright 2025. All Rights Reserved by MedPath