{"id":"lactulose-oral-solution","safety":{"commonSideEffects":[{"rate":null,"effect":"Abdominal cramping"},{"rate":null,"effect":"Bloating"},{"rate":null,"effect":"Flatulence"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"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.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:33:48.663Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Constipation"},{"name":"Hepatic encephalopathy"}]},"trialDetails":[{"nctId":"NCT07454408","phase":"PHASE1, PHASE2","title":"Evaluation of the Outcome of Fecal Microbiota Transplantation","status":"NOT_YET_RECRUITING","sponsor":"Air Force Military Medical University, China","startDate":"2026-03-07","conditions":"Hepatic Encephalopathy, Fecal Microbiota Transplantation, TIPS","enrollment":40},{"nctId":"NCT07084350","phase":"NA","title":"Combination of Lactulose and Polyethylene Glycol Electrolytes Powder (PEG-ELS) for Bowel Preparation in Type II Diabetes Mellitus Patients","status":"NOT_YET_RECRUITING","sponsor":"General Hospital of Shenyang Military Region","startDate":"2025-08-25","conditions":"Type II Diabetes Mellitus","enrollment":254},{"nctId":"NCT07065942","phase":"NA","title":"Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients","status":"RECRUITING","sponsor":"Peking Union Medical College Hospital","startDate":"2023-07-01","conditions":"Diabetes Mellitus, Constipation - Functional","enrollment":60},{"nctId":"NCT07037394","phase":"PHASE4","title":"A Trial for Comparing Rifaximin, Probiotic and L-ornithine- L Aspartate With Lactulose in Overt Hepatic Encephalopathy.","status":"COMPLETED","sponsor":"Qurratul Ain Jamil","startDate":"2024-12-02","conditions":"Overt Hepatic Encephalopathy","enrollment":252},{"nctId":"NCT05700695","phase":"PHASE1","title":"Intravenous BCAA for HE in ACLF (BCAA-HE-ACLF)","status":"COMPLETED","sponsor":"Post Graduate Institute of Medical Education and Research, Chandigarh","startDate":"2023-01-17","conditions":"Hepatic Encephalopathy, Acute-On-Chronic Liver Failure","enrollment":114},{"nctId":"NCT06802042","phase":"NA","title":"Effect of Lactobacillus DSM17938+ on Functional Constipation and Intestinal Flora in Pregnant Women","status":"RECRUITING","sponsor":"Peking Union Medical College Hospital","startDate":"2025-01-09","conditions":"Functional Constipation (FC)","enrollment":40},{"nctId":"NCT04073290","phase":"PHASE4","title":"Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose","status":"RECRUITING","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","startDate":"2020-01-21","conditions":"Hepatic Encephalopathy, Cirrhosis, Liver, Portal Hypertension","enrollment":238},{"nctId":"NCT06748638","phase":"PHASE4","title":"Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for Colonoscopy","status":"ENROLLING_BY_INVITATION","sponsor":"Haifeng Lan","startDate":"2024-09-01","conditions":"Lactulose, Bowel Preparation","enrollment":444},{"nctId":"NCT06738550","phase":"NA","title":"Effect of Agave Inulin on Constipation and Quality of Life in Peritoneal Dialysis Patients.","status":"ENROLLING_BY_INVITATION","sponsor":"NIN Institute","startDate":"2023-03-01","conditions":"Constipation, Peritoneal Dialysis (PD), CKD","enrollment":45},{"nctId":"NCT06368895","phase":"PHASE1","title":"Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment","status":"RECRUITING","sponsor":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","startDate":"2021-04-07","conditions":"Hepatic Encephalopathy, Dysbiosis","enrollment":60},{"nctId":"NCT05878639","phase":"NA","title":"Efficacy and Safety of Lactulose for Bowel Preparation in Patients With Inflammatory Bowel Disease","status":"COMPLETED","sponsor":"Second Affiliated Hospital of Wenzhou Medical University","startDate":"2023-03-28","conditions":"IBD","enrollment":140},{"nctId":"NCT05341180","phase":"PHASE2, PHASE3","title":"Efficacy of Polyethylene Glycol vs Lactulose With Isabgol in Acute Fissure-in-Ano: PEGASIS Trial","status":"COMPLETED","sponsor":"All India Institute of Medical Sciences, Bhubaneswar","startDate":"2022-05-27","conditions":"Anal Fissure, Constipation","enrollment":144},{"nctId":"NCT05920213","phase":"PHASE4","title":"Efficacy of L-Ornithine L-Aspartate and Polyethylene Glycol in Cirrhotic Patients With Overt Hepatic Encephalopathy","status":"UNKNOWN","sponsor":"Jinnah Postgraduate Medical Centre","startDate":"2023-10","conditions":"Hepatic Encephalopathy Stage 2, Hepatic Encephalopathy Stage 3, Hepatic Encephalopathy Stage 4","enrollment":360},{"nctId":"NCT05687409","phase":"PHASE4","title":"Synbiotics Interventions for Managing Cirrhosis and Its Complications","status":"COMPLETED","sponsor":"First Affiliated Hospital of Zhejiang University","startDate":"2019-11-24","conditions":"Cirrhosis, Liver, Metagonimiasis","enrollment":120},{"nctId":"NCT04582942","phase":"NA","title":"Improved Bowel Preparation Method for Colonoscopy Based on Different Risk Stratification","status":"COMPLETED","sponsor":"Renmin Hospital of Wuhan University","startDate":"2020-08-06","conditions":"Bowel Preparation Before Colonoscopy","enrollment":2028},{"nctId":"NCT05648318","phase":"NA","title":"Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation in Low-risk Patients","status":"COMPLETED","sponsor":"Zhang Xiaofeng,MD","startDate":"2022-01-08","conditions":"Colonic Neoplasms","enrollment":255},{"nctId":"NCT05498714","phase":"NA","title":"Improved Bowel Cleansing Method for Colonoscopy Based on High Risk Population of Bowel Preparation","status":"UNKNOWN","sponsor":"Renmin Hospital of Wuhan University","startDate":"2022-07-18","conditions":"Bowel Preparation Before Colonoscopy","enrollment":150},{"nctId":"NCT03962998","phase":"EARLY_PHASE1","title":"Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability","status":"COMPLETED","sponsor":"MediBeacon","startDate":"2019-10-27","conditions":"Crohn Disease","enrollment":22},{"nctId":"NCT03846843","phase":"PHASE1","title":"OCR002-SP103 - Oral Immediate Release Study","status":"COMPLETED","sponsor":"Ocera Therapeutics, Inc.","startDate":"2016-08-15","conditions":"Cirrhosis","enrollment":30},{"nctId":"NCT04821323","phase":"EARLY_PHASE1","title":"A Study Exploring the Use of Challenge Agents in Healthy Volunteers - Intervention Specific Appendix","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2021-03-10","conditions":"Healthy","enrollment":10},{"nctId":"NCT00255372","phase":"PHASE3","title":"To Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.","status":"COMPLETED","sponsor":"Ipsen","startDate":"2005-04","conditions":"Chronic Constipation","enrollment":88},{"nctId":"NCT04159181","phase":"NA","title":"The Endocrine Colon in Humans","status":"UNKNOWN","sponsor":"University of Copenhagen","startDate":"2018-07-16","conditions":"Healthy","enrollment":10},{"nctId":"NCT01842581","phase":"PHASE4","title":"The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2013-01-08","conditions":"Hepatic Encephalopathy, Cirrhosis","enrollment":222},{"nctId":"NCT03242434","phase":"PHASE1","title":"Investigation of Thermal Injury on Intestinal Permeability in Both Thermal Injury and Healthy Participants","status":"TERMINATED","sponsor":"GlaxoSmithKline","startDate":"2018-01-29","conditions":"Burns","enrollment":18},{"nctId":"NCT03666546","phase":"PHASE4","title":"Blood Glucose Response After Oral Intake of Lactulose in Mildly Constipated Patients With Diabetes Mellitus Type 2","status":"COMPLETED","sponsor":"Fresenius Kabi","startDate":"2018-11-26","conditions":"Diabetes Mellitus, Type 2","enrollment":24},{"nctId":"NCT01811836","phase":"NA","title":"Zinc Resistant Starch Project","status":"COMPLETED","sponsor":"Washington University School of Medicine","startDate":"2013-03","conditions":"Enteropathy","enrollment":20},{"nctId":"NCT02158182","phase":"PHASE4","title":"Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding","status":"COMPLETED","sponsor":"Hospital General de Mexico","startDate":"2014-07","conditions":"Hepatic Encephalopathy","enrollment":88},{"nctId":"NCT03177434","phase":"PHASE4","title":"Efficacy of Dicopeg Junior in Comparison With Lactulose for the Treatment of Functional Constipation in Children Aged 6 Months to 6 Years.","status":"UNKNOWN","sponsor":"Children's Memorial Health Institute, Poland","startDate":"2016-02","conditions":"Constipation","enrollment":102},{"nctId":"NCT02968498","phase":"NA","title":"Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers","status":"COMPLETED","sponsor":"Fresenius Kabi","startDate":"2016-11","conditions":"Blood Glucose","enrollment":24},{"nctId":"NCT02123017","phase":"PHASE2","title":"Efficacy and Safety of Bisacodyl and Lactulose as a Preparation for Colonoscopy","status":"COMPLETED","sponsor":"Cumberland Pharmaceuticals","startDate":"2014-04","conditions":"Colonoscopy Preparation","enrollment":32},{"nctId":"NCT01887470","phase":"PHASE2","title":"2 Regimens of Lactulose for Colonoscopy Preparation in Adults","status":"COMPLETED","sponsor":"Cumberland Pharmaceuticals","startDate":"2013-07","conditions":"Colonoscopy Preparation","enrollment":55},{"nctId":"NCT00508482","phase":"PHASE2","title":"A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation","status":"COMPLETED","sponsor":"Guang'anmen Hospital of China Academy of Chinese Medical Sciences","startDate":"2008-04","conditions":"Constipation","enrollment":475},{"nctId":"NCT01596192","phase":"","title":"PETCT for Diagnosing and Monitoring Acute GVHD","status":"UNKNOWN","sponsor":"Rabin Medical Center","startDate":"2012-05","conditions":"Acute Graft Versus Host Disease","enrollment":30},{"nctId":"NCT00616876","phase":"PHASE2","title":"Lactulose Supplementation in Premature Infants","status":"COMPLETED","sponsor":"Bnai Zion Medical Center","startDate":"2005-02","conditions":"Necrotizing Enterocolitis, Sepsis","enrollment":28}],"_emaApprovals":[],"_faersSignals":[{"count":26,"reaction":"DRUG INEFFECTIVE"},{"count":8,"reaction":"BLOOD GLUCOSE INCREASED"},{"count":8,"reaction":"VOMITING"},{"count":7,"reaction":"ABDOMINAL PAIN UPPER"},{"count":7,"reaction":"DIARRHOEA"},{"count":6,"reaction":"NAUSEA"},{"count":4,"reaction":"ABDOMINAL DISTENSION"},{"count":4,"reaction":"CONSTIPATION"},{"count":4,"reaction":"FLATULENCE"},{"count":4,"reaction":"RECTAL HAEMORRHAGE"}],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Lactulose oral solution","genericName":"Lactulose oral solution","companyName":"Peking Union Medical College Hospital","companyId":"peking-union-medical-college-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"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.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}