Lactulose

Constipation, Hepatic Encephalopathy, Hepatic Encephalopathy

Treatment

6 FDA approvals

18 Active Studies for Lactulose

What is Lactulose

Lactulose

The Generic name of this drug

Treatment Summary

Lactulose is a type of sugar derived from lactose that is commonly used as a laxative. It can also be used to treat a liver disorder called portal-systemic encephalopathy (PSE). Lactulose was first synthesized in 1929 and approved by the FDA in 1977. It is now available in both generic and brand-name versions and is listed on the World Health Organization's List of Essential Medicines. It is usually used after other lifestyle and dietary modifications fail to help with constipation. Lactulose may help to manage PSE but its effectiveness has not been clinically confirmed.

Lactulose

is the brand name

image of different drug pills on a surface

Lactulose Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Lactulose

Lactulose

1966

63

Approved as Treatment by the FDA

Lactulose, also known as Lactulose, is approved by the FDA for 6 uses which include Hepatic Encephalopathy (HE) and prophylaxis of Hepatic encephalopathy .

Hepatic Encephalopathy (HE)

prophylaxis of Hepatic encephalopathy

Constipation

Constipation

Hepatic Encephalopathy

Hepatic Encephalopathy

Effectiveness

How Lactulose Affects Patients

Lactulose is usually taken orally or rectally, and it stays in the digestive system and works mainly within the gut. Its primary effects are to increase the amount of stool and make it softer, which can lead to feeling bloated, burping, passing gas more often, and having diarrhea.

How Lactulose works in the body

Lactulose is a sugar that helps soften stools and increase their water content, making bowel movements more frequent. It also helps treat portal-systemic encephalopathy by acidifying the contents of the colon, which traps ammonia and prevents it from being absorbed back into the bloodstream. The acidity of the colon also kills bacteria that produce ammonia and helps other bacteria use up the trapped ammonia as a source of nitrogen. All of these effects help reduce the amount of excess ammonia in the body.

When to interrupt dosage

The proposed dosage of Lactulose is contingent upon the diagnosed condition, including Hepatic Encephalopathy, Chronic Constipation and Hepatic Encephalopathy. The magnitude of dosage fluctuates as per the mode of delivery (e.g. Oral or Solution) detailed in the table underneath.

Condition

Dosage

Administration

Constipation

, 1000.0 mg/mL, 2000.0 mg/mL, 1.0 mg/mg, 2.0 mg/mg, 667.0 mg, 667.0 mg/mL, 3300.0 mg/mL, 0.95 mg/mg

, Oral, Solution, Solution - Oral, Solution - Oral; Rectal, Oral; Rectal, Powder, for solution - Oral, Powder, for solution, Liquid - Oral, Liquid, Syrup - Oral, Syrup, Powder, Powder - Oral, Syrup - Oral; Rectal, Liquid - Oral; Rectal

Hepatic Encephalopathy

, 1000.0 mg/mL, 2000.0 mg/mL, 1.0 mg/mg, 2.0 mg/mg, 667.0 mg, 667.0 mg/mL, 3300.0 mg/mL, 0.95 mg/mg

, Oral, Solution, Solution - Oral, Solution - Oral; Rectal, Oral; Rectal, Powder, for solution - Oral, Powder, for solution, Liquid - Oral, Liquid, Syrup - Oral, Syrup, Powder, Powder - Oral, Syrup - Oral; Rectal, Liquid - Oral; Rectal

Hepatic Encephalopathy

, 1000.0 mg/mL, 2000.0 mg/mL, 1.0 mg/mg, 2.0 mg/mg, 667.0 mg, 667.0 mg/mL, 3300.0 mg/mL, 0.95 mg/mg

, Oral, Solution, Solution - Oral, Solution - Oral; Rectal, Oral; Rectal, Powder, for solution - Oral, Powder, for solution, Liquid - Oral, Liquid, Syrup - Oral, Syrup, Powder, Powder - Oral, Syrup - Oral; Rectal, Liquid - Oral; Rectal

Warnings

Lactulose Contraindications

Condition

Risk Level

Notes

low galactose diet

Do Not Combine

Pulse Frequency

Do Not Combine

There are 20 known major drug interactions with Lactulose.

Common Lactulose Drug Interactions

Drug Name

Risk Level

Description

Alloin

Minor

The risk or severity of adverse effects can be increased when Lactulose is combined with Alloin.

Bisacodyl

Minor

The risk or severity of adverse effects can be increased when Lactulose is combined with Bisacodyl.

Bisoxatin

Minor

The risk or severity of adverse effects can be increased when Lactulose is combined with Bisoxatin.

Calcium polycarbophil

Minor

The risk or severity of adverse effects can be increased when Lactulose is combined with Calcium polycarbophil.

Carboxymethylcellulose

Minor

The risk or severity of adverse effects can be increased when Lactulose is combined with Carboxymethylcellulose.

Lactulose Toxicity & Overdose Risk

The lowest toxic dose of lactulose in mice is 48.8 mL/kg and more than 30 mL/kg in rats. Overdosing on lactulose may cause abdominal cramps, diarrhea, and should be treated with fluid and electrolyte replacement. Lactulose should only be used during pregnancy when necessary and with caution in nursing women. No evidence of fertility issues has been found in rats, mice, and rabbits. There is limited or no information on using lactulose in children or its long-term mutagenic or carcinogenic potential in humans.

image of a doctor in a lab doing drug, clinical research

Lactulose Novel Uses: Which Conditions Have a Clinical Trial Featuring Lactulose?

25 active clinical trials are presently underway to assess the potential of Lactulose to ameliorate Hepatic Encephalopathy, Chronic Constipation and Hepatic Encephalopathy.

Condition

Clinical Trials

Trial Phases

Hepatic Encephalopathy

0 Actively Recruiting

Constipation

18 Actively Recruiting

Phase 2, Not Applicable, Phase 4, Phase 3, Phase 1

Hepatic Encephalopathy

0 Actively Recruiting

Lactulose Reviews: What are patients saying about Lactulose?

5

Patient Review

5/23/2021

Lactulose for Impaired Brain Function due to Liver Disease

Lactulose has been a godsend for me. It's solved my encephalitis issue and really cleansed my system thoroughly. I would likely be in an institution or have passed away if it weren't for this medication, coma or not.

5

Patient Review

9/24/2016

Lactulose for Incomplete or Infrequent Bowel Movements

Just two tablespoons of this product completely relieved my constipation within a day.

5

Patient Review

5/5/2014

Lactulose for Incomplete or Infrequent Bowel Movements

3.7

Patient Review

9/8/2015

Lactulose for Impaired Brain Function due to Liver Disease

After years of constipation, I was finally recommended magnesium by a friend. It works like clockwork now; no more issues whatsoever!

3.7

Patient Review

1/29/2018

Lactulose for High Amount of Ammonium in the Blood

I was prescribed this medication for my liver disease, which causes high levels of ammonia in my blood. This treatment also helped with my diarrhea-predominant IBS. It's a shame that it's so expensive because it's an effective treatment for two conditions.

3.7

Patient Review

5/8/2014

Lactulose for Incomplete or Infrequent Bowel Movements

3

Patient Review

6/29/2015

Lactulose for Incomplete or Infrequent Bowel Movements

I have hepatic encepalopathy and my doctor recommended this treatment alongside another drug. The lactulose is incredibly sweet and thick, making it hard to keep down without vomiting. Additionally, I've been having a lot of gas since starting the medication. That said, I do think it's helping with brain fog so I'll probably continue taking it.

3

Patient Review

3/23/2021

Lactulose for Incomplete or Infrequent Bowel Movements

After my first dose of Lactulose, I experienced severe cramping in my back. This was incredibly painful and made me worry that something worse was happening. Thankfully, it did help with the constipation issue; however, I would not recommend it to others because of the intense pain that accompanied it.

3

Patient Review

5/17/2017

Lactulose for Incomplete or Infrequent Bowel Movements

This medicine helped me as it said it would, but I found out that olive oil does the same thing. After doing some research, I realized that long-term use of laxatives can damage my liver and kidneys, so I started taking two tablespoons of olive oil every morning on an empty stomach. This has saved my organs and me from further harm.

3

Patient Review

6/28/2014

Lactulose for Incomplete or Infrequent Bowel Movements

I'm feeling much better now, thanks to this treatment.

2.7

Patient Review

10/23/2014

Lactulose for Impaired Brain Function due to Liver Disease

Unfortunately, this medication caused me a lot of cramping as well as increased my number of bowel movements. This made it difficult to leave the house and also left me feeling exhausted.

2.7

Patient Review

6/11/2015

Lactulose for Incomplete or Infrequent Bowel Movements

I started lactulose and my cheeks got red and puffy. Is this a reaction? It really hurts. Please advise.

2.7

Patient Review

5/16/2014

Lactulose for Impaired Brain Function due to Liver Disease

This medication has helped me a lot by reducing pain, cramping, and hemorrhoids. I haven't experienced any negative side effects, although I do have several bowel movements each day.

2

Patient Review

3/8/2016

Lactulose for High Amount of Ammonium in the Blood

Though this medicine has been successful in keeping my ammonia levels down, I have had to adjust my lifestyle significantly to accommodate for the increased trips to the bathroom. Additionally, the taste is quite bad so I always take it with orange juice. All things considered, though, I would rather take this than the alternative.

1

Patient Review

8/23/2017

Lactulose for Impaired Brain Function due to Liver Disease

I have not seen any benefits from this treatment.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about lactulose

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is lactulose a laxative?

"Lactulose is a laxative made from lactose that is used to treat chronic constipation and to either treat or prevent hepatic encephalopathy or coma. These latter two conditions are disorders of the brain that can come about as a result of liver disease."

Answered by AI

Is lactulose a laxative or stool softener?

"This medication is a laxative that is used to treat constipation. It may help increase the number of bowel movements per day as well as the number of days you have a bowel movement. Lactulose is a colonic acidifier that works by increasing stool water content and softening the stool. It is a man-made sugar solution."

Answered by AI

What are the side effects of taking lactulose?

"Try to relax because tension makes tummy pain worse

The text is discussing different stomach problems and how to deal with them. Diarrhoea can be avoided by drinking lots of fluids. Bloating can be prevented by taking lactulose between meals. Wind can be reduced by avoiding foods that cause it. Feeling sick can be avoided by eating smaller meals. Being sick can be prevented by not eating for a while. Stomach pain can be reduced by relaxing."

Answered by AI

What is the best time to take lactulose?

"When is the best time to take lactulose?

Lactulose is typically administered twice a day, once in the morning and once at night. Ideally, these times are divided by 10-12 hours, sometime between 7 and 8 am, for example, and between 7 and 8 pm."

Answered by AI

Clinical Trials for Lactulose

Image of Lindenwood University in Saint Charles, United States.

Weizmannia Coagulans for Gut Health

18 - 50
All Sexes
Saint Charles, MO

This study will evaluate the effects of supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 on gastrointestinal health in healthy, physically active adults. The primary objective is to determine whether daily intake of this probiotic strain improves symptoms of constipation and related gastrointestinal function compared with placebo. Approximately 30 healthy men and women aged 18 to 50 years will be enrolled in a randomized, double-blind, placebo-controlled, crossover trial. Participants will complete two 4-week supplementation periods, one with Weizmannia (Bacillus) coagulans JBI-YZ6.3 and one with placebo, separated by a 4-week washout period. The total duration of participation will be approximately 13 to 14 weeks, including screening and testing visits. Gastrointestinal symptoms will be assessed at baseline and after each supplementation period using validated questionnaires, with particular focus on the constipation domain of the Gastrointestinal Symptom Rating Scale (GSRS). Secondary outcomes will include additional gastrointestinal symptom domains and markers of perceived gut comfort and function. This study is designed to determine whether supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 produces clinically meaningful improvements in gastrointestinal symptoms in physically active adults compared with placebo.

Recruiting
Paid Trial

Lindenwood University

Chad M Kerksick, PhD

Image of Banner - University Medical Center South in Tucson, United States.

Dexmedetomidine + Dexamethasone for Postoperative Pain

18 - 75
All Sexes
Tucson, AZ

The goal of this clinical study is to improve upon the standard practice of utilizing nerve blocks to enhance the satisfaction of patients undergoing shoulder, or foot and ankle surgery regarding their quality of pain control, the duration of their nerve blocks, as well as the avoidance of opioid medications and subsequently their undesirable side effects. The researchers hypothesize that dexmedetomidine and dexamethasone (Dex-Dex) will work synergistically as adjuncts in a low, non-weight based formula. This would allow the investigators to improve patient satisfaction by providing them with a superior means of pain control that is longer in duration with a decreased probability of unwanted side effects. The proposed clinical study will be a prospective, randomized control trial.

Phase 1 & 2
Waitlist Available

Banner - University Medical Center South

Ronald Tang, MD

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Kiwifruit Extract for Constipation in Children

4 - 17
All Sexes
Hamilton, Canada

The goal of this pilot feasibility randomized controlled trial is to determine whether Actazin (kiwifruit extract) is a feasible and effective alternative to polyethylene glycol 3350 (PEG 3350) for maintenance therapy in children with functional constipation (FC). This study will include children aged 4 to 17 years who meet the Rome IV criteria for functional constipation. The main questions it aims to answer are: 1. Is it feasible to conduct a definitive, multi-centre trial comparing Actazin to PEG 3350 in children with FC? 2. What are the within-group differences in clinical outcomes such as stool frequency, abdominal pain, and laxative use over a 4-week period? Researchers will compare chewable Actazin tablets with placebo PEG 3350 powder to PEG 3350 powder with placebo Actazin tablets to see if Actazin is a viable non-pharmacologic natural health product alternative for treating FC. Participants will: Undergo an initial bowel cleanout using PEG 3350 and bisacodyl. Following, they will be randomized to one of two groups: 1. Actazin chewable tablets (titrate to effect: 600-2400 mg/day) + placebo PEG 3350 2. PEG 3350 (dose based on age and titratable to effect) + placebo Actazin chewable tablets Participants will take the assigned intervention daily for 4 weeks and complete a daily bowel diary recording stool frequency, consistency (Bristol Stool Scale), abdominal pain, and laxative use. They will have weekly follow-ups via phone or electronic survey to assess adherence, medication use, and adverse events. Additionally, a bi-weekly follow-up will be conducted for an additional 8 weeks to track longer-term outcomes. Outcomes: Primary feasibility outcomes include consent rate, adherence to allocated intervention, and 4-week follow-up completion rate. Secondary clinical outcomes include resolution of FC (Rome IV criteria), weekly stool frequency, abdominal pain episodes, use of rescue laxatives, and treatment palatability. This study is being conducted at McMaster Children's Hospital and is funded by the Hamilton Academic Health Sciences Organization (HAHSO). Data collection will be managed using the Lumedi™ platform, and safety will be overseen by a Data Safety Monitoring Board (DSMB).

Phase 2 & 3
Waitlist Available

Hamilton Health Sciences

Elyanne Ratcliffe, MD

Image of University of Alberta in Edmonton, Canada.

Pelvic Health Rehabilitation for Breast and Gynecologic Cancer

18+
Female
Edmonton, Canada

The GYVE study aims at testing an online program (eModule) to help people who have had breast or gynecologic cancer and are experiencing pelvic health issues like urinary incontinence and pain during sex. These cancers and their treatments can cause significant pelvic health problems, affecting daily life and quality of life. Physiotherapy can help, but access is often limited due to costs and other barriers. The study will involve 20 participants from Quebec and Edmonton, who will take part in a 12-week program with weekly online group sessions led by a physiotherapist. Topics include pelvic floor muscle training, use of vaginal moisturizers, hydration, diet, and pain management. Led by experts in cancer rehabilitation and pelvic health, the study aims to provide valuable information on the feasibility and effectiveness of the eModule, potentially leading to broader implementation to help more people with lived experience of cancer.

Recruiting
Has No Placebo

University of Alberta (+1 Sites)

Have you considered Lactulose clinical trials?

We made a collection of clinical trials featuring Lactulose, we think they might fit your search criteria.
Go to Trials

Have you considered Lactulose clinical trials?

We made a collection of clinical trials featuring Lactulose, we think they might fit your search criteria.
Go to Trials