Lactulose (Synthetic Disaccharide Laxative)

Evidence Level
Moderate
5 Clinical Trials
6 Documented Benefits
3/5 Evidence Score

Lactulose is a synthetic sugar built from galactose and fructose. It passes through the small intestine essentially unchanged, and in the colon bacteria ferment it into acids while it holds water in the stool. In the United States it is a prescription drug (labels carry Rx Only) for constipation and for portal-systemic encephalopathy, a brain complication of advanced liver disease; in the UK adults can buy it from pharmacies. It is a drug first, and this page treats it that way. At 10 to 20 g a day it is an effective osmotic laxative, but independent pooled analyses found polyethylene glycol works better. At 2 to 10 g a day, small trials, several run by a lactulose manufacturer, show more bifidobacteria in stool, a gut flora benefit that EU regulators have not accepted as a health claim.

Studied Dose Prebiotic trials 2-10 g/day; laxative 10-20 g/day, up to 40 g; hepatic encephalopathy (Rx) 20-30 g three or four times daily
Active Compound Lactulose (4-O-β-D-galactopyranosyl-D-fructofuranose), a synthetic disaccharide

Benefits

Supports regular bowel movements and softer stool

At 10 to 20 g a day, lactulose holds water in the colon and softens stool, and the US label notes it can take 24 to 48 hours to work. An independent systematic review of adult trials rated the evidence for it as moderate, and EU rules let a food carrying 10 g per serving say it contributes to faster intestinal transit.

Outperformed by polyethylene glycol for constipation

An independent pooled analysis of ten head-to-head trials found polyethylene glycol (PEG) beat lactulose on stool frequency, stool form, abdominal pain relief and the need for extra laxatives. A separate pooled analysis in children found the same pattern: 18% of children on PEG needed another laxative versus 31% on lactulose.

Raises gut bifidobacteria at low prebiotic doses

In small placebo-controlled trials, 2 to 10 g a day raised bifidobacteria in stool over two to six weeks, and in one trial the rise faded within a week of stopping. The recent low-dose trials were run by researchers at Morinaga Milk, which makes lactulose, and EU regulators judged a claimed gut flora benefit, fewer potentially harmful microbes, as not established.

Slightly more frequent bowel movements at 2 g a day

In a crossover trial analyzing 52 healthy Japanese women who had two to four bowel movements a week, two weeks of 2 g a day gave about 4.3 bowel movements a week versus 3.8 on placebo, slightly softer stool and no increase in flatulence. That is a small change, from a manufacturer-run trial, in people without diagnosed constipation.

May support calcium absorption, from one small study

In twelve postmenopausal women, 10 g of lactulose a day for nine days gave measured calcium absorption of about 32% versus 28% on a reference drink, with 5 g in between. The study did not measure bone, and its authors called for research on whether the effect changes calcium balance or age-related bone loss.

Prescription role in advanced liver disease, not a supplement use

US drug labels list portal-systemic encephalopathy, a brain complication of cirrhosis, as a prescription indication at 20 to 30 g three or four times a day. That use needs a physician, dose titration and electrolyte monitoring. It is summarized under clinical trials for context, not as a reason to self-dose.

Mechanism of action

1

Reaches the colon essentially intact

Lactulose is not split or absorbed to any real extent in the small intestine. The US label reports that only small amounts reach the blood, with 3% or less excreted in urine within 24 hours, so almost the whole dose arrives in the colon unchanged, which is where it acts.

2

Osmotic water retention and bacterial fermentation

In the colon, bacteria ferment lactulose mainly to lactic acid, with smaller amounts of formic and acetic acids. The unabsorbed sugar and these acids hold water in the bowel, raising stool water and softening stool, which is the basis of its use as an osmotic laxative.

3

Colonic acidification and ammonia trapping

The acids lower colonic pH, which converts ammonia into the ammonium ion and traps it in the bowel so less is absorbed. Lowering blood ammonia is the rationale for its prescription use in cirrhosis, where ammonia is linked to brain dysfunction.

4

Selective growth of bifidobacteria

Below laxative doses, the main measurable effect is on which bacteria grow. Trials of 2 to 10 g a day raised stool bifidobacteria, and in the 10 g trial total anaerobes and lactobacilli stayed level, consistent with bifidobacteria being efficient users of the sugar.

5

Hydrogen gas production

Fermentation also releases hydrogen gas. That explains the flatulence and bloating many users notice at first, and it is why the label warns that hydrogen buildup could, in theory, ignite during electrocautery at colonoscopy unless the bowel is cleansed with a non-fermentable solution.

Clinical trials

1
Lactulose Versus Polyethylene Glycol - Cochrane Review
PubMed

Cochrane systematic review and meta-analysis of all ten randomized trials comparing lactulose with polyethylene glycol for chronic constipation or fecal impaction (Lee-Robichaud H, Thomas K, Morgan J, Nelson RL 2010, Cochrane Database Syst Rev 2010(7):CD007570, PMID 20614462).

Adults and children with chronic constipation across ten randomized controlled trials.

Polyethylene glycol was better than lactulose for weekly stool frequency, stool form, relief of abdominal pain and the need for additional products. On subgroup analysis the advantage held in both adults and children, except for abdominal pain relief. The reviewers concluded polyethylene glycol should be used in preference to lactulose for chronic constipation.

2
Non-Absorbable Disaccharides in Hepatic Encephalopathy - Cochrane Review
PubMed

Cochrane systematic review of randomized trials of lactulose or lactitol versus placebo or no intervention, and of lactulose versus lactitol (Gluud LL, Vilstrup H, Morgan MY 2016, Cochrane Database Syst Rev 2016(5):CD003044, PMID 27153247).

1,828 people with cirrhosis in 38 randomized trials covering prevention and treatment of hepatic encephalopathy.

Compared with placebo or no intervention, the disaccharides were associated with lower mortality (RR 0.59; 24 trials, 1,487 participants) and less hepatic encephalopathy (RR 0.58; 22 trials, 1,415 participants), both graded moderate quality. Only eight trials had a low risk of bias for mortality, and all had a high risk of bias for other outcomes. Lactulose and lactitol did not differ. One author disclosed speaker payments from Norgine. This is prescription drug use in liver disease.

3
Secondary Prophylaxis of Hepatic Encephalopathy - Open-Label RCT
PubMed

Open-label randomized controlled trial of lactulose versus placebo after recovery from an episode of hepatic encephalopathy (Sharma BC, Sharma P, Agrawal A, Sarin SK 2009, Gastroenterology 137(3):885-91, 891.e1, PMID 19501587).

140 patients with cirrhosis enrolled after recovering from hepatic encephalopathy; 125 analyzed over a median follow-up of 14 months.

Overt encephalopathy recurred in 12 of 61 patients (19.6%) on lactulose versus 30 of 64 (46.8%) on placebo (P = .001). Deaths (5 versus 11) and readmissions for other causes did not differ significantly. Because the trial was open-label, patients and doctors knew the assignment, which adds some risk of bias.

4
Two Grams of Lactulose in Healthy Women - Crossover RCT
PubMed

Randomized, double-blind, placebo-controlled crossover trial of 2 g/day lactulose for two weeks (Sakai Y, Seki N, Hamano K, Ochi H, Abe F, Masuda K, Iino H 2019, Benef Microbes 10(6):629-639, PMID 31131617). Five of the seven authors are employees of Morinaga Milk Industry, a lactulose manufacturer.

60 healthy Japanese women with two to four bowel movements a week; 52 analyzed, with a three-week washout between periods.

Bowel movement frequency was 4.28 a week on lactulose versus 3.83 on placebo, with slightly softer stools, larger stool volume and less straining. Bifidobacteria made up 25.3% of stool bacteria on lactulose versus 18.2% on placebo. Flatulence did not differ. The effects are small and each treatment period lasted only two weeks.

5
Ten Grams a Day and Fecal Bifidobacteria - Parallel RCT
PubMed

Randomized, double-blind, parallel-group trial of lactulose 5 g twice daily versus sucrose for six weeks (Bouhnik Y, Attar A, Joly FA, Riottot M, Dyard F, Flourié B 2004, Eur J Clin Nutr 58(3):462-6, PMID 14985684).

16 healthy volunteers.

Fecal bifidobacteria were higher on lactulose than on sucrose (P=0.03), while total anaerobes, lactobacilli, stool pH, fecal bile acids and neutral sterols did not change. Excess flatus was more common on lactulose but very mild, and bloating did not differ. With 16 participants, this is a small trial.

Side effects and drug interactions

Common Potential side effects

Gas, belching, bloating and cramping are common at first; US labeling reports them in about 20% of patients on prescription doses.
Too high a dose causes diarrhea, with a risk of fluid loss, low potassium and high sodium.
Nausea and vomiting have been reported.
Infants given lactulose can develop low sodium and dehydration; in the UK, children under 14 need a prescription.
Contains small amounts of galactose and lactose: not for anyone on a low-galactose diet, and the label advises caution in diabetes.
Hydrogen from fermentation is a theoretical ignition hazard during electrocautery at colonoscopy; tell the endoscopist you take it.
Older or frail adults on it for more than six months should have electrolytes checked periodically, per US labeling.

Important Drug interactions

Other laxatives: US labeling advises against combining them, especially early in prescription therapy for liver disease.
Neomycin and possibly other oral anti-infectives: removing colonic bacteria may interfere with the fermentation lactulose depends on.
Nonabsorbable antacids: may blunt the drop in colonic pH that lactulose is meant to produce.
Diuretics and other potassium-lowering drugs: diarrhea from too much lactulose can add to potassium loss.
Insulin and other glucose-lowering drugs: high doses supply some galactose and lactose and can affect blood sugar, so the label advises caution in diabetes.

Frequently asked questions about Lactulose (Synthetic Disaccharide Laxative)

What is Lactulose?

Lactulose is a synthetic sugar built from galactose and fructose. It passes through the small intestine essentially unchanged, and in the colon bacteria ferment it into acids while it holds water in the stool.

What is Lactulose used for?

Lactulose is researched primarily for Gut Health. At 10 to 20 g a day, lactulose holds water in the colon and softens stool, and the US label notes it can take 24 to 48 hours to work.

What is the recommended dosage of Lactulose?

The clinically studied dose is Prebiotic trials 2-10 g/day; laxative 10-20 g/day, up to 40 g; hepatic encephalopathy (Rx) 20-30 g three or four times daily Always follow the product label and check with a healthcare provider for personal advice.

Is Lactulose safe, and does it have side effects?

For most healthy adults, Lactulose is well tolerated at studied doses. Reported effects can include: Gas, belching, bloating and cramping are common at first; US labeling reports them in about 20% of patients on prescription doses. Too high a dose causes diarrhea, with a risk of fluid loss, low potassium and high sodium. It may also interact with some medications. Lactulose is not right for everyone, so check with a healthcare provider first if you are pregnant or breastfeeding, have a medical condition, or take prescription medication.

Does Lactulose interact with any medications?

Possible interactions include: Other laxatives: US labeling advises against combining them, especially early in prescription therapy for liver disease. Neomycin and possibly other oral anti-infectives: removing colonic bacteria may interfere with the fermentation lactulose depends on. If you take prescription medication, check with a pharmacist or doctor before using it.

How strong is the scientific evidence for Lactulose?

NutraSmarts rates the evidence for Lactulose as Moderate (3 out of 5). It is backed by 5 clinical trials and 9 cited references summarized on this page. A higher rating reflects more, larger, and better-designed human studies.

References(9 citations)

Evidence ratings on NutraSmarts are based on the totality of human clinical research, with emphasis on randomized controlled trials, meta-analyses, and systematic reviews. The references below directly support claims made throughout this page.

  1. Lee-Robichaud H, Thomas K, Morgan J, Nelson RL. Lactulose versus Polyethylene Glycol for Chronic Constipation. Cochrane Database Syst Rev. 2010;2010(7):CD007570..PubMedUsed to support: Pooled all ten randomized trials comparing the two laxatives and found polyethylene glycol better than lactulose for stool frequency, stool form, abdominal pain relief and need for additional products, in adults and children; the basis for the comparison benefit on this page.
  2. Ramkumar D, Rao SS. Efficacy and safety of traditional medical therapies for chronic constipation: systematic review. Am J Gastroenterol. 2005;100(4):936-71..PubMedUsed to support: Systematic review of randomized adult trials from 1966 to 2003 that found moderate (Grade B) evidence supporting lactulose for chronic constipation, alongside Grade A evidence for polyethylene glycol; supports the bowel regularity benefit.
  3. Gordon M, MacDonald JK, Parker CE, Akobeng AK, Thomas AG. Osmotic and stimulant laxatives for the management of childhood constipation. Cochrane Database Syst Rev. 2016;2016(8):CD009118..PubMedUsed to support: In six pediatric trials (465 participants), PEG gave more stools per week than lactulose, and 18% of children on PEG versus 31% on lactulose needed additional laxatives; evidence quality was low or very low, and no comparison showed lactulose superior to other agents.
  4. Gluud LL, Vilstrup H, Morgan MY. Non-absorbable disaccharides versus placebo/no intervention and lactulose versus lactitol for the prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2016;2016(5):CD003044..PubMedUsed to support: Across 38 trials in 1,828 people with cirrhosis, lactulose and lactitol were associated with lower mortality and less hepatic encephalopathy than placebo or no intervention (moderate quality), with most trials at high risk of bias; describes the prescription use, not a supplement benefit.
  5. Sharma BC, Sharma P, Agrawal A, Sarin SK. Secondary prophylaxis of hepatic encephalopathy: an open-label randomized controlled trial of lactulose versus placebo. Gastroenterology. 2009;137(3):885-91, 891.e1..PubMedUsed to support: Open-label trial in which overt hepatic encephalopathy recurred in 19.6% of patients on lactulose versus 46.8% on placebo over a median 14 months, with no significant difference in deaths; supports the prescription-use section.
  6. Bouhnik Y, Attar A, Joly FA, Riottot M, Dyard F, Flourié B. Lactulose ingestion increases faecal bifidobacterial counts: a randomised double-blind study in healthy humans. Eur J Clin Nutr. 2004;58(3):462-6..PubMedUsed to support: In 16 healthy volunteers, 10 g/day of lactulose for six weeks raised fecal bifidobacteria versus sucrose while lactobacilli, total anaerobes and stool pH did not change, with mild excess flatus; supports the low-dose prebiotic benefit and mechanism.
  7. Sakai Y, Seki N, Hamano K, Ochi H, Abe F, Masuda K, Iino H. Prebiotic effect of two grams of lactulose in healthy Japanese women: a randomised, double-blind, placebo-controlled crossover trial. Benef Microbes. 2019;10(6):629-639..PubMedUsed to support: Manufacturer-run crossover trial in 52 analyzed women: 2 g/day for two weeks modestly raised bowel movement frequency (4.28 versus 3.83 a week) and stool bifidobacteria, without more flatulence; supports the 2 g benefit and the industry-funding caveat.
  8. Van den Heuvel EG, Muijs T, Van Dokkum W, Schaafsma G. Lactulose stimulates calcium absorption in postmenopausal women. J Bone Miner Res. 1999;14(7):1211-6..PubMedUsed to support: Crossover isotope study in 12 postmenopausal women: fractional calcium absorption was 27.7% on the reference, 30.0% on 5 g and 32.2% on 10 g lactulose for nine days, significant only at 10 g; bone outcomes were not measured.
  9. Sakai Y, Ochi H, Tanaka M. Lactulose Ingestion Induces a Rapid Increase in Genus Bifidobacterium in Healthy Japanese: A Randomised, Double-Blind, Placebo-Controlled Crossover Trial. Microorganisms. 2022;10(9):1719..PubMedUsed to support: Crossover trial by Morinaga Milk researchers in 36 healthy Japanese adults. 4 g/day for two weeks raised the fecal Bifidobacterium share above placebo within two days, with no significant change in overall microbiota beta diversity, and the share returned to its original level within a week of stopping. Supports the low-dose prebiotic benefit, its transience and the manufacturer caveat.