Evigrade

Lactoferrin

AEMPS

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

ATC code: J05AX-LACTOFERRIN

Brand names – supplements: Jarrow Lactoferrin, Life Extension Lactoferrin Caps, Pure Encapsulations Lactoferrin, Symbiotics Colostrum with LactoferrinSupplements are not tested in clinical trials and are not registered as medications.

Updated · Methodology

Indications

B

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.

ICD-10: P77 · ICD-11: KB88.Z

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.

C

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.

ICD-10: B98.0 · ICD-11: DA42.1

D

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.

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

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.

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

Pregnancy: can you take Lactoferrin?

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: can you take Lactoferrin?

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.

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

Label mentions11 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • antiácidosclass named in the label
    «La absorción del hierro puede incrementarse por la administración simultánea de 200 mg de ácido ascórbico y reducirse con la administración simultánea de antiácidos, colestiramina o inhibidores de la…»

    AEMPS, section 4.5 · Open on CIMA

  • «La absorción del hierro puede incrementarse por la administración simultánea de 200 mg de ácido ascórbico y reducirse con la administración simultánea de antiácidos, colestiramina o inhibidores de la…»

    AEMPS, section 4.5 · Open on CIMA

  • bifosfonatosclass named in the label
    «Los derivados del hierro pueden reducir la absorción o biodisponibilidad de las tetraciclinas, quinolonas, micofenolato mofetilo, bifosfonatos, penicilamina, hormonas tiroideas, levodopa, carbidopa…»

    AEMPS, section 4.5 · Open on CIMA

  • «La absorción del hierro puede incrementarse por la administración simultánea de 200 mg de ácido ascórbico y reducirse con la administración simultánea de antiácidos, colestiramina o inhibidores de la…»

    AEMPS, section 4.5 · Open on CIMA

  • inhibidores de la bomba de protonesclass named in the label
    «La absorción del hierro puede incrementarse por la administración simultánea de 200 mg de ácido ascórbico y reducirse con la administración simultánea de antiácidos, colestiramina o inhibidores de la…»

    AEMPS, section 4.5 · Open on CIMA

  • «La absorción del hierro puede incrementarse por la administración simultánea de 200 mg de ácido ascórbico y reducirse con la administración simultánea de antiácidos, colestiramina o inhibidores de la…»

    AEMPS, section 4.5 · Open on CIMA

  • «Los derivados del hierro pueden reducir la absorción o biodisponibilidad de las tetraciclinas, quinolonas, micofenolato mofetilo, bifosfonatos, penicilamina, hormonas tiroideas, levodopa, carbidopa…»

    AEMPS, section 4.5 · Open on CIMA

  • «La absorción del hierro puede incrementarse por la administración simultánea de 200 mg de ácido ascórbico y reducirse con la administración simultánea de antiácidos, colestiramina o inhibidores de la…»

    AEMPS, section 4.5 · Open on CIMA

  • «La absorción del hierro puede incrementarse por la administración simultánea de 200 mg de ácido ascórbico y reducirse con la administración simultánea de antiácidos, colestiramina o inhibidores de la…»

    AEMPS, section 4.5 · Open on CIMA

  • quinolonasclass named in the label
    «Los derivados del hierro pueden reducir la absorción o biodisponibilidad de las tetraciclinas, quinolonas, micofenolato mofetilo, bifosfonatos, penicilamina, hormonas tiroideas, levodopa, carbidopa…»

    AEMPS, section 4.5 · Open on CIMA

  • tetraciclinasclass named in the label
    «Los derivados del hierro pueden reducir la absorción o biodisponibilidad de las tetraciclinas, quinolonas, micofenolato mofetilo, bifosfonatos, penicilamina, hormonas tiroideas, levodopa, carbidopa…»

    AEMPS, section 4.5 · Open on CIMA

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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?

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?

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.

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.

Official sources

Direct links to regulator labels. Open in a new tab.

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