Lactulose

Generic Name: Lactulose

Brand Names: Constulose, Enulose, Generlac, Kristalose

Drug Type: Small Molecule

Chemical Formula: C_₁₂H_₂₂O_₁₁

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 constipa...

Indication: Lactulose is indicated for use as a laxative in the treatment of chronic constipation in adults and geriatric patients.
...

Associated Conditions: Constipation, Hepatic Encephalopathy (HE)

Associated Therapies: -

Clinical Trials

BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE

Not Applicable

Not yet recruiting

Conditions: Hepatic Encephalopathy
Decompensated Cirrhosis
Minimal Hepatic Encephalopathy

Interventions: Drug: Rifaximin 550 MG
Drug: Oral Branched chain Amino acid
Drug: Lactulose
Drug: Placebo for BCAA
Drug: Placebo for Rifaximin 550mg

First Posted Date: 2024-08-05

Last Posted Date: 2024-08-05

Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Target Recruit Count: 336

Registration Number: NCT06538077

Locations: 🇮🇳
Dr. Madhumita Premkumar, Chandigarh, India
🇮🇳
PGIMER, Chandigarh, India
🇮🇳
Postgraduate Institute of Medical Education and Research, 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: Lactulose
Drug: Rifaximin
Drug: Ornithine Aspartate
Drug: Branched-Chain Amino Acids
Drug: Arginine
Device: plasma exchange

First Posted Date: 2024-07-03

Last Posted Date: 2024-07-08

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

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

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
Drug: Lactulose
Behavioral: TeleTai-Chi (virtual)

First Posted Date: 2023-04-03

Last Posted Date: 2024-10-22

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

Effectiveness of Oral Lactulose Versus Lactulose Enema in Hepatic Encephalopathy

Phase 4

Not yet recruiting

Conditions: Chronic Liver Disease
Hepatic Encephalopathy

Interventions: Drug: Tap water
Drug: Lactulose

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: Drug: Nifuroxazide
Drug: Rifaximin 550Mg Tab
Drug: Lactulose

First Posted Date: 2023-03-06

Last Posted Date: 2024-10-11

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: Drug: Lactulose
Drug: Polyethylene Glycol 3350

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
Drug: Lactulose

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

Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhotic Patients

Early Phase 1

Conditions: Hepatic Encephalopathy

Interventions: Drug: lactulose
Drug: colistin

First Posted Date: 2022-03-15

Last Posted Date: 2022-03-15

Lead Sponsor: Madonna Magdy Fahmy

Target Recruit Count: 316

Registration Number: NCT05279586

Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Phase 4

Conditions: Constipation-predominant Irritable Bowel Syndrome
Functional Dyspepsia

Interventions: Drug: Linaclotide
Drug: Lactulose
Drug: Omeprazol
Drug: Itopride

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

Drug Development Updates

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