Lactoferrin

Bovine colostrum and human-milk glycoprotein supplement marketed as «immune modulator», «iron support» and «antiviral»

ATC code: J05AX-LACTOFERRIN (Lactoferrin (bovine colostrum glycoprotein))

Brand names – supplements

Jarrow Lactoferrin, Life Extension Lactoferrin Caps, Pure Encapsulations Lactoferrin, Symbiotics Colostrum with Lactoferrin

Supplements are not tested in clinical trials and are not registered as medications.

Mechanism of action

Lactoferrin is an iron-binding glycoprotein of the transferrin family, abundant in bovine colostrum (1–5 g/L), human milk (1–3 g/L in mature milk, up to 6 g/L in colostrum), tears, saliva and neutrophils. In the gut pepsin and trypsin partly digest it; the surviving fragment lactoferricin shows antibacterial activity in vitro. Mechanisms include sequestration of free iron (creating bacterial iron starvation), disruption of bacterial cell walls and modulation of TLR signalling and cytokine production. In preterm infants pepsin activity is lower, so intact lactoferrin survives better – this drives the neonatal interest. in 2012 approved bovine lactoferrin as a novel food ingredient for infant formulas and supplements. AEMPS has not registered lactoferrin as a medicine; in Spain it is a complemento alimenticio.

Indications

Necrotising enterocolitis prevention in preterm infants

Adjunct

Lactoferrin has its only indication with serious evidence. The Cochrane Pammi review (2020) pooled 12 RCTs of bovine lactoferrin in preterm infants under 1500 g: 100–300 mg/day orally reduced stage II-III necrotising enterocolitis (RR about 0.40, 95% CI 0.28–0.57) and late-onset sepsis. The effect was stronger in earlier smaller trials. The large UK ELFIN RCT 2019 (2200 infants under 1500 g, 150 mg/kg/day to 34 weeks corrected age) did not show a reduction in mortality or severe late sepsis – the result split the neonatal community. The decision in a unit is made jointly by the head of the unit and the neonatologist. No comparable data exist in term infants or adults, so analogies should not be extended. If parents of a preterm infant are offered lactoferrin, discuss with the unit neonatologist what the local protocol shows and which alternatives (donor human milk, probiotics, feeding protocol) are already in place.

Sources

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

Helicobacter pylori infection

Not recommended

Lactoferrin is proposed as an adjunct to standard Helicobacter pylori eradication (triple or quadruple therapy). The Zou meta-analysis (Helicobacter 2009) pooled 9 RCTs with 1343 patients: adding lactoferrin 200–400 mg/day to standard eradication raised eradication rates from 76% to 86%. The trials were small, heterogeneous and mostly from China and Italy. The Maastricht VI / Florence Consensus 2022 recommends regimen selection based on local resistance (bismuth quadruple therapy or levofloxacin-containing regimen); lactoferrin is not mentioned in the main recommendations. Adjuvant addition to a prescribed regimen is discussed with the treating gastroenterologist – it does not replace PPIs and antibiotics and is not justified as monotherapy. If lactoferrin was bought instead of prescribed eradication, discuss with a doctor; incomplete eradication with persistent symptoms and positive serology raises the risk of ulcer recurrence and MALT lymphoma.

Sources

Immune support and respiratory infection care

Not recommended

Lactoferrin is a protein found in milk and other body fluids; in supplements it gets promoted for boosting immunity and preventing colds and respiratory infections. Reliable evidence for this use is missing – good studies have not shown that taking lactoferrin makes colds less frequent or milder. The substance itself is harmless in this role. To catch fewer respiratory infections, seasonal flu vaccination, hand washing, and enough sleep have far better support.

Sources

EFSA NDA Panel: Scientific Opinion on bovine lactoferrin as a novel food ingredient (2012)

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Official sources

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AEMPS / CIMA

Spanish Medicines Information Centre (CIMA)

Label dated: 06/14/2022

Safety

Contraindications

Known cow-milk protein allergy
Galactosemia
Severe hepatic or renal impairment without follow-up

Serious adverse effects

Severe allergic reactions in milk-protein-allergic patients (including anaphylaxis, single case reports)

Common adverse effects

Gastrointestinal discomfort, flatulence
Loose stools in the first days of use
Skin rash in predisposed users

PregnancyFDA N

Bovine lactoferrin safety in human pregnancy has not been systematically studied in RCTs. Lactoferrin is naturally present in human milk and is considered a safe food component. EFSA approved bovine lactoferrin in 2012 as a novel food ingredient. AEMPS advises avoiding supplements without therapeutic indication during pregnancy; the doctor decides.

Breastfeeding

Lactoferrin is naturally present in maternal milk. Additional bovine lactoferrin supplementation during lactation provides no benefit and is usually not justified. The decision is made by the paediatrician and the mother's doctor.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Frequently asked

What is Lactoferrin used for?

Lactoferrin is evaluated for the following indications with varying evidence strength: Necrotising enterocolitis prevention in preterm infants (evidence tier B), Helicobacter pylori infection (evidence tier C), Immune support and respiratory infection care (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Lactoferrin?

Common side effects of Lactoferrin (≥ 1 in 100): Gastrointestinal discomfort, flatulence, Loose stools in the first days of use, Skin rash in predisposed users. See the Safety section for uncommon and serious reactions.

Is Lactoferrin safe during pregnancy?

FDA category N. Bovine lactoferrin safety in human pregnancy has not been systematically studied in RCTs. Lactoferrin is naturally present in human milk and is considered a safe food component. EFSA approved bovine lactoferrin in 2012 as a novel food ingredient. AEMPS advises avoiding supplements without therapeutic indication during pregnancy; the doctor decides.

Is Lactoferrin compatible with breastfeeding?

Who should not take Lactoferrin?

Lactoferrin is contraindicated in: Known cow-milk protein allergy; Galactosemia; Severe hepatic or renal impairment without follow-up. Full list in the Safety section.

Mechanism of action

Indications

Necrotising enterocolitis prevention in preterm infants

Adjunct

Sources

Safety

Contraindications

Known cow-milk protein allergy
Galactosemia
Severe hepatic or renal impairment without follow-up

Serious adverse effects

Severe allergic reactions in milk-protein-allergic patients (including anaphylaxis, single case reports)

Common adverse effects

Gastrointestinal discomfort, flatulence
Loose stools in the first days of use
Skin rash in predisposed users

PregnancyFDA N

Breastfeeding

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Frequently asked

What is Lactoferrin used for?

What are the side effects of Lactoferrin?

Is Lactoferrin safe during pregnancy?

Is Lactoferrin compatible with breastfeeding?

Who should not take Lactoferrin?

Lactoferrin is contraindicated in: Known cow-milk protein allergy; Galactosemia; Severe hepatic or renal impairment without follow-up. Full list in the Safety section.