Constulose

Constipation, Hepatic Encephalopathy, Hepatic Encephalopathy
Treatment
6 FDA approvals
18 Active Studies for Constulose

What is Constulose

LactuloseThe Generic name of this drug
Treatment SummaryLactulose is a synthetic sugar used to treat constipation and portal-systemic encephalopathy (PSE). It was developed in 1929, but its use as a laxative wasn’t discovered until the 1960s. It was approved by the FDA in 1977 and is now available without a prescription. It is on the World Health Organization’s List of Essential Medicines as one of the most effective and safe medicines. While it is an option for treating constipation, it is not clear how effective it is for treating PSE, since it is unethical to withhold it from patients in a placebo study.
Lactuloseis the brand name
image of different drug pills on a surface
Constulose 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 Constulose Affects PatientsLactulose is most often taken as a pill or enema. It doesn't absorb into the body, so it stays in the gut and produces its effects there. The main effects are increased stool amounts and softer stools, which can cause bloatedness, belching, frequent passing of gas, and diarrhea.
How Constulose works in the bodyLactulose is a synthetic sugar that helps with constipation and portal-systemic encephalopathy (PSE). When it is broken down by bacteria in the large intestine, it creates organic acids and small amounts of formic and acetic acids. These acids increase the water content in your stool, making it softer. This laxative effect usually takes 24 to 48 hours to become apparent. At the same time, it also makes the colon more acidic, which helps to treat PSE. This acidic environment prevents ammonia from being absorbed back into the body. It also kills off bacteria that produce ammonia, which further reduces the amount of

When to interrupt dosage

The advised dosage of Constulose is contingent upon the recognized malady, for example, Hepatic Encephalopathy, Chronic Constipation and Hepatic Encephalopathy. The measure of dosage changes as per the technique of delivery (e.g. Oral or Solution) delineated in the table beneath.
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, Powder, for solution - Oral, Liquid - Oral, Liquid, Syrup - Oral, Syrup, Powder, Syrup - Oral; Rectal, Liquid - Oral; Rectal, Powder - Oral
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, Powder, for solution - Oral, Liquid - Oral, Liquid, Syrup - Oral, Syrup, Powder, Syrup - Oral; Rectal, Liquid - Oral; Rectal, Powder - Oral
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, Powder, for solution - Oral, Liquid - Oral, Liquid, Syrup - Oral, Syrup, Powder, Syrup - Oral; Rectal, Liquid - Oral; Rectal, Powder - Oral

Warnings

Constulose has two contraindications and should not be consumed in combination with the ailments listed in the following table.Constulose Contraindications
Condition
Risk Level
Notes
low galactose diet
Do Not Combine
Pulse Frequency
Do Not Combine
There are 20 known major drug interactions with Constulose.
Common Constulose 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.
Constulose Toxicity & Overdose RiskThe toxic dose of lactulose for mice has been found to be 48.8 mL/kg and more than 30 mL/kg in rats. Taking too much lactulose may cause stomach cramps and diarrhea, so it is important to replace lost fluids and electrolytes. Although there is no evidence that lactulose affects fertility in animals, it has not been studied in pregnant or breastfeeding women, so use with caution. There is also limited data regarding the safety and efficacy of lactulose in children. The long-term effects of lactulose on mutagenic potential or cancer risk in humans are unknown.

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

25 active clinical trials are currently being conducted to assess the potential of Constulose to mitigate Hepatic Encephalopathy, Chronic Constipation and related conditions.
Condition
Clinical Trials
Trial Phases
Hepatic Encephalopathy
0 Actively Recruiting
Constipation
18 Actively Recruiting
Not Applicable, Phase 2, Phase 4, Phase 3, Phase 1
Hepatic Encephalopathy
0 Actively Recruiting

Constulose Reviews: What are patients saying about Constulose?

5Patient Review
10/15/2014
Constulose for Incomplete or Infrequent Bowel Movements
This treatment has been very effective for me. I take it because I'm on narcotic pain medication, and it's helped my liver problems a lot. It tastes good and I use it with magnesium sulfate. I drink one gallon of water per day to keep everything working correctly, and I'm really happy with the results.
5Patient Review
11/18/2021
Constulose for High Amount of Ammonium in the Blood
After my gallbladder removal, I was really struggling. So I spoke with my doctor and he prescribed me this medication. He said to not eat for 24 hours and drink lots of water, and take the medicine every two hours. And after just the second dose, I was feeling so much better!
5Patient Review
12/23/2008
Constulose for Incomplete or Infrequent Bowel Movements
This medication has helped me a lot, though I have noticed some increased gas pains. I will continue to use it as my doctor suggests.
4.3Patient Review
1/15/2010
Constulose for Incomplete or Infrequent Bowel Movements
Lactulose has been extremely effective for my five-year-old twins. They have a bowel movement at least once or twice daily, and their stools are neither hard nor mushy. I highly recommend that people suffering from similar problems ask their doctor about this treatment option.
3.7Patient Review
10/22/2007
Constulose for Incomplete or Infrequent Bowel Movements
This medicine gives me a lot of bloating before it actually works. It's not as effective as I had hoped.
3.3Patient Review
11/24/2008
Constulose for Impaired Brain Function due to Liver Disease
I'm grateful that this medicine exists- it saved my life. I was in complete liver failure in 2002 and, as of 2008, I'm still here.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about constulose

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

What is the difference between lactulose and Constulose?

"Constulose is a solution which helps to make the colon more acidic and promote laxation, indicated for the treatment of constipation."

Answered by AI

How long do you take Constulose?

"You should take 1-2 tablespoons (15-30 mL) of lactulose every day. The dose may be increased to 60 mL every day if necessary. You may need to wait 24-48 hours to see results."

Answered by AI

What are side effects of lactulose?

"Lie on your side and bring your knees up to your chest to help ease the pain.

Drink lots of fluids to avoid dehydration, take lactulose between meals, lie on your side and bring your knees up to help ease stomach pain."

Answered by AI

What is Constulose used for?

"Lactulose is a medication that is used as a laxative to treat constipation. It may help to increase the number of bowel movements per day, as well as the number of days you have a bowel movement. Lactulose works by increasing stool water content and softening the stool, which makes it easier to pass."

Answered by AI

Clinical Trials for Constulose

Image of Center for Nutraceutical and Dietary Supplement Research in Memphis, United States.

Inno Cleanse for Abdominal Bloating

18+
All Sexes
Memphis, TN
The purpose of the present study is to investigate the impact of a natural dietary supplement, Inno Cleanse™, to reduce bloating in a population of otherwise healthy men and women, who claim to feel frequently bloated. Inno CleanseTM dietary supplement is manufactured in the United States under current Good Manufacturing Practices (cGMP) and is marketed by InnoSupps as a digestive health aid. It is sold in the United States on the company's website, Amazon, and in many large retail outlets. It remains a very popular product, with close to 1.4 million units sold since 2020, with a reported 66,000 units sold in the past three months. Despite the prevalence of dietary supplements identifying as digestive aids, detoxification, and cleanses, very little research has been done to determine their effectiveness. The product appears to be well-designed, with multiple ingredients included which have scientific evidence of effectiveness. That said, and despite the overall positive reviews, there is no known clinical research to support the product's effectiveness. Therefore, the aim of this study is to evaluate the efficacy of the Inno Cleanse product to reduce bloating and result in other positive outcomes (weight loss). This study will be run as a double-blind placebo-controlled trial, in which subjects will use the product or placebo for two weeks. It is hypothesized that treatment with the dietary supplement Inno Cleanse will result in reduced bloating, as evidenced by self-reported reductions in bloating and hunger, as well as moderate weight loss and a reduction in body circumference measures due to the reduced bloating. In addition, multiple anecdotal reports of improved skin health have been noted in those using the product. Additionally, routine blood and urine sample analysis will be performed as a secondary outcome, as a safety measure.
Recruiting
Paid Trial
Center for Nutraceutical and Dietary Supplement ResearchRichard Bloomer, 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 SouthRonald Tang, MD
Have you considered Constulose clinical trials? We made a collection of clinical trials featuring Constulose, we think they might fit your search criteria.Go to Trials
Image of Hamilton Health Sciences in Hamilton, Canada.

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 SciencesElyanne 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 Constulose clinical trials? We made a collection of clinical trials featuring Constulose, we think they might fit your search criteria.Go to Trials
Have you considered Constulose clinical trials? We made a collection of clinical trials featuring Constulose, we think they might fit your search criteria.Go to Trials
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