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Lactulose (4-O-β-D-galactopyranosyl-D-fructose)

Lactulose

Research reviewed: Up until 03/2026

Lactulose (Lactulose (4-O-β-D-galactopyranosyl-D-fructose)) is a dietary supplement with 7 published peer-reviewed studies involving 406 participants, researched for Constipation, Hepatic Encephalopathy, Prebiotic & Microbiome Effects.

7
Studies
406
Participants
1997–2019
Research Span

Evidence at a Glance

Strength is scored by study design, sample size, study type, and outcomes

Overall: Strong Evidence

Constipation

Moderate
3 studies 2 of 3 positive 226 participants 2 human

Hepatic Encephalopathy

Moderate
2 studies 2 of 2 positive 92 participants 1 human

Prebiotic & Microbiome Effects

Moderate
2 studies 1 of 2 positive 88 participants

Research Visualised

Visual breakdown of the clinical data.

Study Quality Breakdown

What types of studies were conducted

5/7
Randomised
2/7
Double-Blind
2/7
Placebo-Controlled

Participants Per Study

Larger samples = more reliable results

Study 1 (2010)
11
Study 2 (2007)
115
Study 3 (2006)
100
Study 1 (2004)
22
Study 2 (2013)
70
Study 1 (1997)
48
Study 2 (2019)
40

Research Timeline

When the studies were published

1
1997
1
2004
1
2006
1
2007
1
2010
1
2013
1
2019

All Studies

Detailed breakdown of each trial. Click to expand.

Constipation

1

To evaluate lactulose for chronic constipation.

2010 11 participants 2-12 weeks 15-30 mL/day (10-20 g)
Review/Other Positive

Study Type

Systematic review and meta-analysis

Purpose

To evaluate lactulose for chronic constipation.

Dose

15-30 mL/day (10-20 g)

Participants

Meta-analysis of 11 RCTs, 868 patients

Duration

2-12 weeks

Results

Lactulose significantly increased stool frequency (WMD 2.5 bowel movements/week) and improved stool consistency compared to placebo. NNT = 4.

How They Measured It

Stool frequency, stool consistency, straining, patient satisfaction

Read full study
2

To evaluate lactulose for chronic constipation in elderly nursing home residents.

2007 115 participants 12 weeks 15 mL lactulose twice daily
Human Study RCT Double-Blind Placebo Positive

Study Type

Randomised, double-blind, placebo-controlled

Purpose

To evaluate lactulose for chronic constipation in elderly nursing home residents.

Dose

15 mL lactulose twice daily

Participants

115 elderly nursing home residents with chronic constipation

Duration

12 weeks

Results

Lactulose significantly increased bowel movement frequency and reduced need for rescue laxatives. 68% of patients reported satisfactory relief.

How They Measured It

Stool frequency, laxative use, stool consistency

Read full study
3

To compare lactulose with PEG for chronic constipation in children.

2006 100 participants 8 weeks Lactulose 1-2 mL/kg/day vs PEG 0.4 g/kg/day
Human Study RCT Mixed

Study Type

Randomised controlled trial

Purpose

To compare lactulose with PEG for chronic constipation in children.

Dose

Lactulose 1-2 mL/kg/day vs PEG 0.4 g/kg/day

Participants

100 children aged 2-14 with chronic constipation

Duration

8 weeks

Results

PEG was slightly more effective than lactulose for stool frequency, but both were effective. Lactulose was better tolerated with fewer taste complaints.

How They Measured It

Stool frequency, fecal incontinence episodes, abdominal pain

Read full study

Hepatic Encephalopathy

1

To evaluate lactulose for prevention and treatment of hepatic encephalopathy.

2004 22 participants Various (2 weeks to 12 months) 30-60 mL/day adjusted to produce 2-3 soft stools/day
Review/Other Positive

Study Type

Systematic review and meta-analysis

Purpose

To evaluate lactulose for prevention and treatment of hepatic encephalopathy.

Dose

30-60 mL/day adjusted to produce 2-3 soft stools/day

Participants

Meta-analysis of 22 RCTs, 1415 patients with cirrhosis

Duration

Various (2 weeks to 12 months)

Results

Lactulose significantly reduced risk of hepatic encephalopathy (RR 0.47, 95% CI 0.37-0.60). Also showed reduction in mortality (RR 0.59) and improved cognitive function.

How They Measured It

Prevention of HE episodes, mortality, cognitive test scores

Read full study
2

To evaluate lactulose for prevention of HE after acute variceal bleeding.

2013 70 participants 5 days 30-60 mL lactulose per day
Human Study RCT Positive

Study Type

Randomised controlled trial

Purpose

To evaluate lactulose for prevention of HE after acute variceal bleeding.

Dose

30-60 mL lactulose per day

Participants

70 cirrhotic patients with acute variceal bleeding

Duration

5 days

Results

Lactulose significantly reduced incidence of HE after variceal bleeding (14% vs 40% control). Blood ammonia was significantly lower in lactulose group.

How They Measured It

Incidence of hepatic encephalopathy, blood ammonia levels

Read full study

Prebiotic & Microbiome Effects

1

To evaluate prebiotic effects of low-dose lactulose on gut microbiome.

1997 48 participants 4 weeks 5-10 g/day lactulose (sub-laxative dose)
Human Study RCT Double-Blind Placebo Positive

Study Type

Randomised, double-blind, placebo-controlled

Purpose

To evaluate prebiotic effects of low-dose lactulose on gut microbiome.

Dose

5-10 g/day lactulose (sub-laxative dose)

Participants

48 healthy adults

Duration

4 weeks

Results

Sub-laxative doses of lactulose significantly increased fecal Bifidobacterium counts and SCFA (especially butyrate) production. Stool pH decreased.

How They Measured It

Fecal Bifidobacterium and Lactobacillus counts, SCFA levels, stool pH

Read full study
2

To evaluate lactulose effects on gut microbiome in cirrhosis patients.

2019 40 participants 8 weeks 30 mL/day lactulose
Human Study RCT Mixed

Study Type

Randomised controlled trial

Purpose

To evaluate lactulose effects on gut microbiome in cirrhosis patients.

Dose

30 mL/day lactulose

Participants

40 patients with compensated cirrhosis

Duration

8 weeks

Results

Lactulose shifted gut microbiome towards more beneficial composition (increased Bifidobacterium, decreased Enterobacteriaceae). Plasma endotoxin levels decreased.

How They Measured It

Fecal microbiome (16S rRNA), plasma endotoxin, systemic inflammation

Read full study

Frequently Asked Questions

Common questions about Lactulose research

What does the research say about Lactulose?

There are currently 7 peer-reviewed studies on Lactulose (Lactulose (4-O-β-D-galactopyranosyl-D-fructose)), involving 406 total participants. Research covers Constipation, Hepatic encephalopathy, Prebiotic effects and 1 more areas. The overall evidence strength is rated as Strong.

How strong is the evidence for Lactulose?

The evidence is currently rated as "Strong Evidence". This rating is based on study design quality (randomisation, blinding, placebo controls), sample sizes, study types (5 human studies), and reported outcomes.

What health goals has Lactulose been studied for?

Lactulose has been researched for: Constipation, Hepatic encephalopathy, Prebiotic effects, Gut health. Each area has its own body of evidence which you can explore in the study breakdowns above.

Are the studies on Lactulose based on human trials?

Yes, 5 out of 7 studies are human trials. Human trials carry more weight in our evidence scoring system.