Lactase (β-Galactosidase)

Lactase / β-galactosidase (EC 3.2.1.108)
Evidence Level
Strong
2 Clinical Trials
4 Documented Benefits
4/5 Evidence Score

Lactase is a digestive enzyme that hydrolyzes lactose (milk sugar) into glucose and galactose, the two simple sugars the body can absorb directly. Most of the world’s adults make much less lactase after early childhood (lactase non-persistence), although the exact global share is uncertain, with prevalence above 90% in some East Asian, West African and Native American populations. Supplemental lactase is made by fermentation, usually from the mould Aspergillus oryzae or the yeast Kluyveromyces lactis. Taken with dairy, it breaks down part of the lactose in that meal. In small placebo-controlled trials it lowered breath hydrogen (a sign of undigested lactose) and usually eased symptoms, but results vary between products and between people. It is the active ingredient in lactose-intolerance tablets such as Lactaid. Most adults with lactose intolerance can handle about 12 to 15 g of lactose (roughly a cup of milk) with no supplement at all.

Studied Dose About 3,000 or 6,000 units taken with milk containing 20 g lactose; the EU claim requires at least 4,500 FCC units with each lactose-containing meal.
Active Compound Lactase enzyme (β-galactosidase) measured in FCC (Food Chemical Codex) units or ALU (Acid Lactase Units)

Benefits

Better digestion of the lactose in a dairy meal

Several small placebo-controlled trials found that lactase taken with lactose lowers breath hydrogen, a direct sign that less lactose reached the colon undigested, and most also found milder bloating, cramping, flatulence or diarrhea. Examples: 16 adults given enzyme-treated milk (Corazza 1992), 24 adults given 9,900 FCC units with 50 g lactose (Sanders 1992), and 60 patients in a three-arm trial (Ojetti 2010). The benefit has limits. About 6,000 units worked better than 3,000 with 20 g lactose, but neither dose made a significant difference against 50 g lactose in water (Lin 1993). In a 10-person comparison of three brands, one lowered hydrogen without easing symptoms while another eased symptoms (Ramirez 1994). In 96 patients given a standard dose without placebo, only about 22% had a normal breath test afterwards (Ibba 2014). The EU authorises the claim that lactase improves lactose digestion at 4,500 FCC units or more per meal. An independent review found most people with lactose intolerance tolerate 12 to 15 g lactose, about a cup of milk, without any aid (Shaukat 2010).

Easier to keep dairy foods in the diet

For people who get symptoms from lactose, taking lactase with a meal can make milk and other dairy foods easier to eat, and dairy supplies calcium, protein, riboflavin and vitamin B12. No trial has measured whether taking lactase raises nutrient intake or improves bone health, so this is a practical point rather than a proven effect. Hard cheeses and lactose-free milk contain very little lactose, and yoghurt with live cultures is often better tolerated than milk, so these are other ways to keep dairy in the diet.

Use in children with lactose intolerance

In a double-blind trial of 18 children (average age 11) with lactose intolerance, lactase tablets taken just before a lactose drink cut peak breath hydrogen from about 60 ppm to 7 ppm and reduced pain, bloating and diarrhea compared with placebo (Medow 1990). For infants and young children with diarrheal illness, most trial evidence concerns switching to lactose-free formula or food (a 2013 Cochrane review of 33 trials). One 2026 trial in 50 hospitalised infants in Pakistan found fewer ongoing diarrhea episodes with lactase drops added to milk than with lactose-free formula, but it had no placebo group. That is medical care for an illness, not a supplement use: a child with diarrhea, or an infant with feeding symptoms, needs a doctor's assessment.

Background: how lactose-free dairy is made (not an effect of taking lactase)

Dairy manufacturers add lactase to milk in processing to make lactose-free products. At high lactose concentrations the enzyme also forms small amounts of galacto-oligosaccharides (GOS), a type of fibre, so some lactose-free milks contain traces of GOS. This happens in the factory. Taking a lactase tablet is not a way to get GOS, and no health effect of this is claimed for lactase supplements.

Mechanism of action

1

Hydrolysis of β-1,4 glycosidic bond in lactose

Lactase is a β-galactosidase enzyme that catalyzes hydrolysis of the β-1,4 glycosidic bond connecting glucose and galactose in the lactose disaccharide. The released glucose and galactose are absorbed via SGLT1 and GLUT2 transporters in the small intestine, while undigested lactose ferments in the colon producing gas, water, and short-chain fatty acids responsible for intolerance symptoms.

2

Two main supplement sources: Aspergillus oryzae vs. Kluyveromyces lactis

Aspergillus oryzae lactase works best in mildly acidic conditions (around pH 4.5 to 5), close to the stomach's pH after a meal, and is the usual source in tablets and capsules. Kluyveromyces lactis lactase works best near neutral pH (about 6.5 to 7) and is mainly used to pre-treat milk to make lactose-free dairy. Trials of commercial tablets disagree on whether brands are interchangeable: one found three products worked about equally per unit of enzyme (Lin 1993), while another found clear differences between brands (Ramirez 1994).

3

Brush border location of native lactase

Native human lactase is anchored in the brush border of small intestinal enterocytes (specifically the villus tip cells of the proximal jejunum). Lactase non-persistence is genetic: the LCT gene's lactase-phlorizin hydrolase enzyme is downregulated after weaning in most mammals; persistence into adulthood is the evolutionary exception (developed in Northern European, some African, and Middle Eastern populations who domesticated dairy).

Clinical trials

1
Three Commercial Lactase Products at Two Lactose Loads (Lin 1993)
PubMed

Placebo-controlled comparison of Lactogest soft gels (about 3,000 or 6,000 units), Lactaid caplets and DairyEase chewable tablets (about 6,000 units each), fed with milk containing 20 g lactose or with 50 g lactose in water. Outcomes: breath hydrogen and GI symptoms. Lin MY et al., Dig Dis Sci 1993;38(11):2022-7 (University of Minnesota).

Adult lactose maldigesters; group size is not stated in the abstract.

With 20 g lactose in milk, all three products sharply reduced peak and total breath hydrogen, and symptoms were significantly milder. About 6,000 units lowered total hydrogen more than about 3,000 units, and the three product forms performed about equally per unit of enzyme. With 50 g lactose in water, hydrogen fell only slightly and not significantly, and symptoms did not differ from control: the large lactose load overwhelmed both doses.

2
Single Chewable Lactase Dose With a 50 g Lactose Challenge (Sanders 1992)
PubMed

Randomized, double-blind, placebo-controlled crossover trial. Three chewable lactase tablets (9,900 FCC units total) or placebo, taken after fasting with 8 oz of whole milk to which lactose powder was added (50 g lactose in total), at least one week apart. Outcomes: breath hydrogen, plasma glucose and symptoms over four days. Sanders SW et al., Clin Pharm 1992;11(6):533-8; lead author affiliated with TheraTech, Inc.

24 adults with lactose intolerance, confirmed by a breath hydrogen rise of 20 ppm or more after lactose.

Peak breath hydrogen was significantly lower after lactase than after placebo, and 21 of 24 subjects had a lower hydrogen curve. Cramping, belching, flatulence and diarrhea ratings were lower in the first 8 hours, and bloating in the next 8 hours. Plasma glucose did not differ. A small single-dose trial with an industry-affiliated lead author.

Side effects and drug interactions

Common Potential side effects

Generally extremely well-tolerated; very few reported adverse effects
Rare allergic reactions to the enzyme source (Aspergillus mould or yeast) in sensitized individuals. Lactase does NOT help cow's milk protein allergy, a different condition in which dairy can cause serious allergic reactions; people with a milk allergy must still avoid dairy. Lactase does not make dairy safe for people with galactosemia, because it releases galactose.
Works only on lactose eaten at about the same time: in trials it was taken immediately before or with the lactose (15 minutes before in one trial), so a dose taken long after a meal is unlikely to help

Important Drug interactions

No significant drug interactions
Not known to affect medication absorption
No drug interactions have been reported, and none are expected, since the enzyme acts on lactose in the gut

Frequently asked questions about Lactase (β-Galactosidase)

How much lactase should I take?

Lactase is dosed in enzyme units (FCC). Trials used about 3,000 to 9,900 units, taken right before or with the first bite of a dairy-containing meal, and the EU health claim applies to at least 4,500 FCC units per meal. The right amount depends on how much lactose you eat: in one trial, 3,000 to 6,000 units did not significantly help against a very large load of 50 g lactose in water, although in another trial 9,900 units did help with 50 g lactose given in milk. Most people with lactose intolerance can handle 12 to 15 g of lactose, about a cup of milk, without any supplement.

What is lactase used for?

Lactase is the digestive enzyme that breaks down lactose, the sugar in milk. People with lactose intolerance lack enough of it, so a lactase supplement taken with dairy can reduce gas, bloating, and digestive upset from that meal, although results vary between products and between people.

When should I take lactase?

Take it right before or as you start eating dairy, since it needs to be present with the lactose to work. It does not help much if taken long after the meal. Product labels often suggest a second dose during a long meal; this has not been tested in trials.

Is lactase safe?

Lactase supplements are generally very safe and well tolerated, since they simply provide a digestive enzyme. They are an alternative to avoiding dairy for people with lactose intolerance. Those with a milk-protein allergy (not lactose intolerance) still need to avoid dairy, since lactase does not help with that.

What is Lactase?

Lactase is a digestive enzyme that hydrolyzes lactose (milk sugar) into glucose and galactose, the two simple sugars the body can absorb directly. Most of the world’s adults make much less lactase after early childhood (lactase non-persistence), although the exact global share is uncertain, with prevalence above 90% in…

What is the recommended dosage of Lactase?

The clinically studied dose is About 3,000 or 6,000 units taken with milk containing 20 g lactose; the EU claim requires at least 4,500 FCC units with each lactose-containing meal. Always follow the product label and check with a healthcare provider for personal advice.

Is Lactase safe, and does it have side effects?

For most healthy adults, Lactase is well tolerated at studied doses. Reported effects can include: Generally extremely well-tolerated; very few reported adverse effects Rare allergic reactions to the enzyme source (Aspergillus mould or yeast) in sensitized individuals. It may also interact with some medications. Lactase 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 Lactase interact with any medications?

Possible interactions include: No significant drug interactions Not known to affect medication absorption If you take prescription medication, check with a pharmacist or doctor before using it.

How strong is the scientific evidence for Lactase?

NutraSmarts rates the evidence for Lactase as Strong (4 out of 5). It is backed by 2 clinical trials and 10 cited references summarized on this page. A higher rating reflects more, larger, and better-designed human studies.

References(10 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. Ojetti V, Gigante G, Gabrielli M, Ainora ME, Mannocci A, Lauritano EC, Gasbarrini G, Gasbarrini A The effect of oral supplementation with Lactobacillus reuteri or tilactase in lactose intolerant patients: randomized trial Eur Rev Med Pharmacol Sci. 2010;14(3):163-70.PubMedUsed to support: Randomized trial in 60 lactose-intolerant patients (20 per group). Tilactase (a lactase enzyme) taken 15 minutes before a lactose breath test normalised the test more often than placebo and lowered peak breath hydrogen and symptom scores. It also outperformed 10 days of Lactobacillus reuteri. A small trial using a laboratory lactose challenge rather than a normal dairy meal.
  2. Shaukat A, Levitt MD, Taylor BC, MacDonald R, Shamliyan TA, Kane RL, Wilt TJ Systematic review: effective management strategies for lactose intolerance Ann Intern Med. 2010;152(12):797-803. doi: 10.7326/0003-4819-152-12-201006150-00241.PubMedUsed to support: Systematic review of 36 randomized trials of lactose-intolerance management. Moderate-quality evidence showed most adults with lactose intolerance or malabsorption tolerate 12 to 15 g lactose (about a cup of milk). Evidence for lactose-reduced milk, probiotics and other treatments was judged insufficient, and differences between studies prevented pooling. The authors concluded more studies are needed to establish how well treatments work.
  3. Corazza GR, Benati G, Sorge M, Strocchi A, Calza G, Gasbarrini G beta-Galactosidase from Aspergillus niger in adult lactose malabsorption: a double-blind crossover study Aliment Pharmacol Ther. 1992;6(1):61-6. doi: 10.1111/j.1365-2036.1992.tb00545.x.PubMedUsed to support: Double-blind crossover trial in 16 adults with lactose malabsorption and intolerance. Adding a beta-galactosidase from Aspergillus niger to 400 ml of milk significantly lowered peak and cumulative breath hydrogen and gastrointestinal symptom scores compared with placebo. The enzyme was mixed into the milk rather than taken as a tablet, and one enzyme preparation was compared with placebo; no dose-response was tested.
  4. Montalto M, Gallo A, Santoro L, D'Onofrio F, Curigliano V, Covino M, Cammarota G, Grieco A, Gasbarrini A, Gasbarrini G Low-dose lactose in drugs neither increases breath hydrogen excretion nor causes gastrointestinal symptoms Aliment Pharmacol Ther. 2008;28(8):1003-12. doi: 10.1111/j.1365-2036.2008.03815.x.PubMedUsed to support: Not a lactase study. Randomized double-blind crossover trial in 77 lactose maldigesters with intolerance: a capsule containing 400 mg lactose (a suggested upper limit for lactose in a tablet or capsule) caused no more breath hydrogen or symptoms than placebo. Shows that small amounts of lactose in medicines are generally tolerated without lactase.
  5. Lin MY, Dipalma JA, Martini MC, Gross CJ, Harlander SK, Savaiano DA Comparative effects of exogenous lactase (beta-galactosidase) preparations on in vivo lactose digestion Dig Dis Sci. 1993;38(11):2022-7. doi: 10.1007/BF01297079.PubMedUsed to support: In lactose maldigesters, three commercial lactase products sharply reduced breath hydrogen and symptoms when taken with milk containing 20 g lactose; about 6,000 units lowered hydrogen more than about 3,000, and soft-gel, caplet and chewable forms performed about equally per unit of enzyme. With 50 g lactose in water, neither dose significantly reduced hydrogen or symptoms.
  6. Sanders SW, Tolman KG, Reitberg DP Effect of a single dose of lactase on symptoms and expired hydrogen after lactose challenge in lactose-intolerant subjects Clin Pharm. 1992;11(6):533-8.PubMedUsed to support: Randomized double-blind crossover trial in 24 lactose-intolerant adults: 9,900 FCC units of chewable lactase taken with milk carrying 50 g lactose lowered peak breath hydrogen and early cramping, belching, flatulence, diarrhea and bloating ratings compared with placebo. Single dose, small sample, lead author from a pharmaceutical company.
  7. Ramirez FC, Lee K, Graham DY All lactase preparations are not the same: results of a prospective, randomized, placebo-controlled trial Am J Gastroenterol. 1994;89(4):566-70.PubMedUsed to support: Randomized placebo-controlled comparison in 10 lactose-intolerant adults given ice cream with 18 g lactose. Only Lactaid lowered breath hydrogen, but it did not reduce symptoms. Lactrase reduced pain and bloating, and Dairy Ease reduced only pain. Commercial lactase products differ in how well they work.
  8. Ibba I, Gilli A, Boi MF, Usai P Effects of exogenous lactase administration on hydrogen breath excretion and intestinal symptoms in patients presenting lactose malabsorption and intolerance Biomed Res Int. 2014;2014:680196. doi: 10.1155/2014/680196.PubMedUsed to support: Uncontrolled study of 96 patients with lactose malabsorption. After a standard oral dose of beta-galactosidase, the breath test became negative in about 22%, improved but stayed positive in about 18%, and was essentially unchanged in about 60%. Response to lactase varies widely between people.
  9. Medow MS, Thek KD, Newman LJ, Berezin S, Glassman MS, Schwarz SM Beta-galactosidase tablets in the treatment of lactose intolerance in pediatrics Am J Dis Child. 1990;144(11):1261-4. doi: 10.1001/archpedi.1990.02150350093034.PubMedUsed to support: Double-blind placebo-controlled study in 18 lactose-intolerant children (mean age 11): lactase tablets taken just before a lactose drink lowered maximum breath hydrogen from about 60 ppm to 7 ppm and reduced abdominal pain, bloating, diarrhea and flatulence. Small single-dose study.
  10. MacGillivray S, Fahey T, McGuire W Lactose avoidance for young children with acute diarrhoea Cochrane Database Syst Rev. 2013;2013(10):CD005433. doi: 10.1002/14651858.CD005433.pub2.PubMedUsed to support: Cochrane review of 33 trials (2,973 children under five with acute diarrhoea, mostly inpatients). Switching to lactose-free products may shorten diarrhoea by about 18 hours (low-quality evidence) and probably halves treatment failure (RR 0.52). The review tested lactose avoidance, not lactase supplements.