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Lactulose oral solution
Lactulose is a non-absorbable disaccharide that draws water into the colon and is metabolized by colonic bacteria to produce organic acids, lowering pH and promoting bowel movements.
Lactulose is a non-absorbable disaccharide that draws water into the colon and is metabolized by colonic bacteria to produce organic acids, lowering pH and promoting bowel movements. Used for Constipation, Hepatic encephalopathy.
At a glance
| Generic name | Lactulose oral solution |
|---|---|
| Sponsor | Peking Union Medical College Hospital |
| Drug class | Osmotic laxative / Prebiotic |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
Lactulose works through osmotic and prebiotic mechanisms. As an osmotic laxative, it increases stool water content by drawing fluid into the intestinal lumen, promoting defecation. Additionally, colonic bacteria ferment lactulose into short-chain fatty acids and gases, which lower colonic pH, inhibit ammonia absorption, and promote the growth of beneficial bacteria, making it particularly useful in hepatic encephalopathy management.
Approved indications
- Constipation
- Hepatic encephalopathy
Common side effects
- Abdominal cramping
- Bloating
- Flatulence
- Diarrhea
- Nausea
Key clinical trials
- Evaluation of the Outcome of Fecal Microbiota Transplantation (PHASE1, PHASE2)
- Combination of Lactulose and Polyethylene Glycol Electrolytes Powder (PEG-ELS) for Bowel Preparation in Type II Diabetes Mellitus Patients (NA)
- Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients (NA)
- A Trial for Comparing Rifaximin, Probiotic and L-ornithine- L Aspartate With Lactulose in Overt Hepatic Encephalopathy. (PHASE4)
- Intravenous BCAA for HE in ACLF (BCAA-HE-ACLF) (PHASE1)
- Effect of Lactobacillus DSM17938+ on Functional Constipation and Intestinal Flora in Pregnant Women (NA)
- Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose (PHASE4)
- Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for Colonoscopy (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lactulose oral solution CI brief — competitive landscape report
- Lactulose oral solution updates RSS · CI watch RSS
- Peking Union Medical College Hospital portfolio CI