Lactococcus rhamnosus

Lactobacillus rhamnosus (Lacticaseibacillus rhamnosus)

1. Identity, Nomenclature, and Classification

1.1 Current and Historical Names

Lactobacillus rhamnosus GG — formally reclassified under current taxonomy as Lacticaseibacillus rhamnosus strain GG (ATCC 53103 / DSM 20021) — is a gram-positive, rod-shaped, non-spore-forming lactic acid bacterium used as an oral probiotic to modulate gut microbiota and mucosal immunity. The older genus designation Lactobacillus remains prevalent in the clinical and scientific literature accumulated before the 2020 taxonomic revision, and the two names are used interchangeably across that body of evidence.

Alternative names and identifiers include: Lactobacillus rhamnosus GG, Lacticaseibacillus rhamnosus GG, LGG, ATCC 53103, DSM 20021, and the commercially recognized "Culturelle strain." Product labels increasingly declare, for example, "Lacticaseibacillus rhamnosus GG (ATCC 53103), formerly classified as Lactobacillus rhamnosus GG (ATCC 53103)"; running literature searches with both the legacy and new names is critical for prior art and meta-analyses.

1.2 Taxonomic Classification

The full scientific classification of the GG strain is: Kingdom: Bacteria; Phylum: Firmicutes; Class: Bacilli; Order: Lactobacillales; Family: Lactobacillaceae; Genus: Lacticaseibacillus; Species: rhamnosus; Strain: GG (ATCC 53103).

Lactobacilli are gram-positive, rod-shaped, facultatively anaerobic or microaerophilic, non-spore-forming, acid-tolerant, and catalase-negative bacteria with DNA G+C content usually less than 50 mol%. Lactobacillus casei, Lactobacillus paracasei, and Lactobacillus rhamnosus are phylogenetically and phenotypically closely related; together they are regarded as the L. casei group, and members are facultatively heterofermentative, with 45–47 mol% DNA G+C content and identical peptidoglycan types (L-Lys-D-Asp).

To characterize the biological function of L. rhamnosus GG, genomic comparisons have been made with its 3.0-Mbp genome against the similarly sized genome of L. rhamnosus LC705; both genomes demonstrated high sequence identity and synteny, punctuated by genomic islands — five in GG and four in LC705.

1.3 Notable Commercially Studied Strains

While L. rhamnosus encompasses many strains, the scientific and regulatory literature has concentrated most rigorously on two:

• LGG (ATCC 53103) — the most clinically studied probiotic strain in the world, primarily associated with gastrointestinal and immunological indications.
• GR-1 — a strain isolated from the urogenital tract and studied extensively for vaginal health applications.

The widely known probiotic strains in the L. casei group — including L. rhamnosus GG — are used worldwide in fermented dairy products or food supplements and as probiotics to enhance host health. These are microbial species with a history of safe use due to their inclusion in a variety of foods. Together with their suitability for large-scale cultivation, this may explain why Lactobacillus rhamnosus is the most studied Lactobacillus species for human application.

1.4 Natural Sources

Lactobacillus rhamnosus has a long history of being used in fermentation and possesses a genome that allows it to adapt to a range of environments, including the human gastrointestinal and urogenital tracts. The species can be recovered from some fermented foods as well as from the intestinal and vaginal tracts, and strains possess a number of characteristics suitable for use in humans.

2. Traditional and Historical Use

2.1 Fermented Food Traditions

The bacterium itself was not identified, named, or deliberately administered until the twentieth century. Consumption of fermented dairy and fermented foods — which naturally contain lactic acid bacteria including L. rhamnosus-like organisms — has a long history for gastrointestinal health and food preservation. For thousands of years, fermented foods have been present in traditional diets around the world and continue to be widely consumed. Historically, communities produced fermented foods within the home, a practice that continues to this day in many settings.

Alongside its use in health supplements, Lactobacillus species have been consumed for centuries through their use in the production of fermented foods such as yoghurt, kimchi, and kefir. The species has a long history in dairy fermentation and is commonly found in yogurt, where it is sometimes added alongside traditional starter cultures; beyond dairy, it has been successfully used to ferment millet, maize, and fruit juices.

In West Africa, fermented milk preparations containing L. rhamnosus have been propagated in traditional milk products. Addition of a starter culture with L. rhamnosus yoba 2012 to milk in lahals led to substantial growth of this probiotic bacterium during fermentation, with a 20- to 60-fold increase in total probiotic bacteria in the first batch after inoculation; a similar increase was observed in a variation of lait caillé prepared with carbohydrate-rich millet granules (thiakry) added prior to fermentation.

2.2 Formal Scientific Discovery

The LGG strain was isolated and named after Sherwood Gorbach and Barry Goldin in the early 1980s and became a model probiotic strain widely studied in pediatric and adult clinical trials. Taxonomic recognition of Lactobacillus-like organisms in dairy and human isolates dates to the 1950s–1960s. The 1980s saw the isolation and description of strain GG; the 1990s–2000s saw clinical RCTs evaluate LGG for pediatric diarrhea and antibiotic-associated diarrhea; the 2000s–2010s brought molecular characterization including SpaCBA pili and genome sequencing; and in 2019–2020, taxonomic reclassification placed the species into the genus Lacticaseibacillus.

3. Key Constituents and Active Compounds

3.1 Surface Structures: SpaCBA Pili

GG-specific genomic islands include genes coding for bacteriophage components, sugar metabolism and transport, and exopolysaccharide biosynthesis. One island found only in L. rhamnosus GG contains genes for three secreted LPXTG-like pilins (spaCBA) and a pilin-dedicated sortase.

The spaCBA-encoded pili on the cell surface of Lactobacillus rhamnosus GG have been identified as key molecules for binding to human intestinal mucus and Caco-2 intestinal epithelial cells. The SpaCBA pilus has been shown to be key for efficient adherence to Caco-2 intestinal epithelial cells and biofilm formation; furthermore, the spaCBA mutant induces elevated interleukin-8 (IL-8) mRNA in Caco-2 cells compared to wild type — an effect possibly involving an interaction of lipoteichoic acid with Toll-like receptor 2 — while a mutant lacking exopolysaccharides but showing increased pili exposure leads to reduced IL-8 expression.

LGG is a very good mucus-adhering Lactobacillus strain compared to other probiotic strains such as L. casei Shirota and L. johnsonii LJ1 and the closely related strain L. rhamnosus Lc705.

3.2 Immunomodulatory Molecules

SpaCBA pili play a significant role in the capacity for adhesion to macrophages and promote bacterial uptake by these phagocytic cells. The SpaCBA pili mediate anti-inflammatory effects by induction of interleukin-10 (IL-10) mRNA and reduction of interleukin-6 (IL-6) mRNA in a murine RAW 264.7 macrophage cell line. These pili appear to mediate these effects indirectly by promoting close contact with the macrophages, facilitating the exertion of anti-inflammatory effects by other surface molecules via as-yet unknown mechanisms.

3.3 Exopolysaccharides and Metabolic Products

Signaling engaged by LGG includes TLR2, modulation of NF-κB and MAPK pathways, upregulation of anti-inflammatory cytokines (IL-10), and tight-junction proteins (ZO-1, claudins, occludin). Strain genes (spaCBA) encode pili; host gene modulation includes increased mucin (MUC2) and tight junction expression in vitro and some in vivo models. Enzymatic activities include β-galactosidase activity in some strains supporting lactose hydrolysis, and bile salt hydrolase (BSH) activity in select strains that alters bile acid pools.

3.4 Mechanisms of Action: Summary

Action is via local mucosal interaction: adhesion to mucus and epithelium, competitive exclusion of pathogens, production of lactic acid and bacteriocins, and modulation of immune cells in gut-associated lymphoid tissue (GALT). Occasional translocation into systemic circulation is possible but rare and pathological, such as in bacteremia.

4. Scientific Evidence by Area of Use

4.1 Acute Infectious Diarrhea in Children

Although previous studies have reported that Lactobacillus rhamnosus GG (LGG) is an effective therapeutic agent for acute diarrhea in children, a recent large, high-quality RCT found no adequate evidence of a beneficial effect of LGG treatment, reflecting evolving evidence.

A 2019 systematic review and meta-analysis of 19 RCTs meeting inclusion criteria showed that, compared with control, LGG administration notably reduced diarrhea duration [mean difference −24.02 hours, 95% CI (−36.58, −11.45)], with more effective results detected at high doses ≥10¹⁰ CFU per day [mean difference −22.56 hours, 95% CI (−36.41, −8.72)] versus lower doses.

Evidence strength: Moderate, though tempered by heterogeneity across studies, variability by geography, and the inclusion of a major high-quality RCT that did not find benefit. Dose appears to matter, with higher CFU doses showing stronger effects.

4.2 Antibiotic-Associated Diarrhea (AAD)

A 2015 systematic review and meta-analysis of 12 RCTs (1,499 participants) found that treatment with LGG compared with placebo or no additional treatment reduced the risk of antibiotic-associated diarrhea in patients from 22.4% to 12.3% (11 RCTs, n=1,308; relative risk RR: 0.49, 95% CI: 0.29–0.83; low quality of evidence). The meta-analysis concluded that LGG is effective in preventing AAD in children and adults treated with antibiotics for any reason; however, the quality of evidence is moderate to low.

In adults specifically, the risk reduction was not statistically significant overall (six RCTs, n=863, RR 0.48, 95% CI 0.20–1.15; low quality of evidence), except in the subset of patients receiving antibiotics as part of Helicobacter pylori eradication therapy (four RCTs, n=280, RR 0.26, 95% CI 0.11–0.59; low quality of evidence).

Evidence on LGG survival under amoxicillin/clavulanate therapy in children is relevant, given the frequent use of this antibiotic combination in children, its association with AAD, and LGG's sensitivity to penicillin that might make the probiotic ineffective under some antibiotic regimens.

Evidence strength: Moderate for children; lower and less consistent for adults in general, though a specific benefit in H. pylori eradication regimens in adults is supported. The quality of evidence across included trials is rated low to moderate by GRADE criteria.

4.3 Irritable Bowel Syndrome (IBS)

The use of Lactobacillus rhamnosus GG as a single strain has been studied in the treatment of IBS in five studies that met criteria for a strain-specific meta-analysis, which found that it significantly reduced pain with moderate heterogeneity (I² = 25.9%). When only studies in children were considered, the positive effect was maintained (I² = 42.7%); however, the beneficial effect was lost across all subgroups in a meta-analysis stratified by diagnostic criteria used for IBS.

Disruption of intestinal barrier homeostasis is an important pathogenic factor in conditions such as IBS, and LGG appears to improve IBS symptoms through mechanisms that are not yet fully characterized.

It is important to note that the clinical effects in IBS are significant but moderate, which is not unexpected given the large subject heterogeneity in IBS patients.

LGG treatment has been shown to reduce abdominal pain in children with functional gastrointestinal disorders, such as irritable bowel syndrome.

Evidence strength: Preliminary to moderate for abdominal pain reduction, particularly in pediatric IBS. Effects in adult IBS are inconsistent and appear to depend on the diagnostic criteria used. Multi-strain preparations may outperform single-strain LGG in adult IBS populations. Evidence overall is rated preliminary.

4.4 Eczema and Atopic Disease Prevention

Eczema prevention was one of the earliest proposed indications for LGG in the perinatal period. In a study published in The Lancet, administration of LGG (10¹⁰ CFU daily, in capsules or in water) in families with a history of atopic disease significantly lowered the risk of eczema at ages 2, 4, and 7. However, allergic rhinitis and asthma tended to be more common in the LGG-treated group.

However, more recent high-quality pooled evidence reverses this optimistic picture. A 2018 systematic review and meta-analysis of five RCTs (889 participants) using GRADE criteria found that high- to moderate-certainty evidence suggests that LGG supplementation — regardless of timing of administration (pre- or postnatal) — did not reduce the risk of eczema. There was also no consistent effect on other allergic outcomes.

Kopp and colleagues were unable to replicate the beneficial results against eczema using a similar protocol and concentration; the reason for these different outcomes is unknown, but it is thought that the different genetic backgrounds of the tested populations (Finnish versus German) might play a role.

Evidence strength: Weak to null for eczema prevention as of the most comprehensive pooled analysis (2018). Earlier positive findings have not been reliably replicated. The evidence is rated high to moderate certainty of no benefit for primary eczema prevention.

4.5 Necrotizing Enterocolitis (NEC) in Preterm Infants

In a phone survey of neonatal intensive care units (NICUs) in the United States, 14% of NICUs reported supplementing probiotics to very low birth weight (VLBW) infants, of which LGG in the form of Culturelle was the most commonly used product; however, randomized trials specifically demonstrating the effectiveness of this probiotic product in decreasing the risk of NEC are lacking.

In preterm neonates, use of probiotic mixtures is increasingly popular and has shown effectiveness in preventing NEC, fungal colonization, and improving feeding tolerance; however, concerns exist about safety and tolerability of long-lasting administration of living microorganisms to non-immunocompetent hosts.

Oral supplementation with LGG (6 × 10⁹ CFU with human milk) has been shown to prevent enteric colonization by Candida species in preterm neonates in a randomized study, although the underlying mechanisms need to be explored.

Evidence strength: Weak to preliminary for LGG specifically in NEC prevention. The broader evidence base supporting probiotic mixtures for NEC prevention in preterm infants on breast milk is stronger, but does not isolate LGG as the active component. Randomized trial evidence specific to LGG monotherapy for NEC is insufficient to draw firm conclusions.

4.6 Vaginal Microbiota and Urogenital Health

The L. rhamnosus species possesses a genome that allows it to adapt to a range of environments, including the human urogenital tract. The GR-1 strain specifically has been studied for vaginal health, while evidence for LGG (GG strain) in this context is more limited.

Oral probiotic supplementation can influence vaginal microbiota; Lactobacillus species taken orally can travel through the digestive tract, survive passage through the anus, cross the perineum, and colonize the vaginal tract — a transit of approximately 7 days.

Evidence strength: Preliminary for L. rhamnosus GG specifically; more substantial for the GR-1 strain. Evidence for bacterial vaginosis treatment with oral L. rhamnosus-containing preparations remains of low to moderate quality and is largely strain-specific to GR-1, not GG.

4.7 Clostridium difficile Infection

Two pilot studies showed promising results for LGG treatment (respectively 10¹⁰ CFU in skim milk and 1.2 × 10⁹ CFU in lyophilized powder daily) of recurrent Clostridium difficile-induced colitis in children, but these should be repeated in larger trials.

Evidence strength: Preliminary and insufficient. Findings in adults are mixed, and current evidence does not support routine clinical recommendation of LGG specifically for CDI prevention or treatment outside of research settings.

4.8 Healthcare-Associated Diarrhea

A meta-analysis of three randomized controlled trials showed that the administration of LGG to children for the duration of hospital stay was associated with significantly lower rates of healthcare-associated diarrhea and symptomatic rotavirus gastroenteritis compared to placebo.

Evidence strength: Moderate for reduction of nosocomial diarrhea in hospitalized children. Limited to pediatric populations in the existing pooled analysis.

5. Body Systems and Health Areas

The primary cellular and tissue targets of L. rhamnosus include intestinal epithelial cells (enterocytes, goblet cells, M cells), the mucus layer (mucin-binding sites), antigen-presenting cells in gut-associated lymphoid tissue (GALT) — notably dendritic cells and macrophages — innate immune receptors on epithelial and immune cells (TLRs, NLRs), and pathogenic bacteria, which are competitively excluded or inhibited by bacteriocins or organic acids.

The systems most reliably associated with evidence in clinical research include:

• Gastrointestinal system: Treatment and prevention of diarrhea (infectious and antibiotic-associated), modulation of IBS symptoms, gut barrier reinforcement, and alteration of gut microbiota composition.
• Immune system: Modulation of innate and adaptive immune responses via TLR2 signaling, cytokine regulation, and enhancement of secretory IgA responses.
• Urogenital system: Maintenance and restoration of vaginal microbiota homeostasis, primarily documented for the GR-1 strain.
• Neonatal/perinatal health: Colonization resistance against pathogens (including Candida) in premature infants, and investigation of NEC risk reduction.

6. Dosage Forms and Doses Reported in Studies

Dosing for L. rhamnosus preparations is expressed in colony-forming units (CFU), not milligrams. Lacticaseibacillus rhamnosus is used in clinical trials at doses typically between 1×10⁸ and 1×10¹¹ CFU/day depending on indication and formulation.

Commercially available dosage forms of LGG include oral capsules, oral powder for reconstitution, and chewable oral tablets; brand examples include Culturelle Digestive Health, Culturelle for Kids, Culturelle Health and Wellness, and related formulations.

Doses from specific studies and clinical reports include:

• Atopic disease prevention (prenatal/perinatal): 10¹⁰ CFU daily, given in capsules or in water, in families with atopic history (Lancet trial).
• Prevention of Candida colonization in preterm neonates: 6 × 10⁹ CFU with human milk, in a randomized study.
• Atopic disease treatment in IgE-sensitized infants: 5 × 10⁹ CFU daily in milk, in two trials.
• Cow's milk allergy (infants): 5 × 10⁹ CFU in capsule form.
• Milk hypersensitivity (adults): 2.6 × 10⁸ CFU daily in milk.
• Acute pediatric diarrhea — higher-dose subgroup: ≥10¹⁰ CFU per day, associated with greater reduction in diarrhea duration in meta-analysis.
• NEC prevention in VLBW infants (NICU use): 2.5 × 10⁹ CFU per day initially, increased to 5 × 10⁹ CFU per day once feedings were advanced, using a single sachet of LGG powder.
• VLBW infants (retrospective Italian NICU cohort): 3 × 10⁹ CFU per day in a single oral dose beginning on the 4th day of life, for 4- to 6-week courses.
• Recurrent C. difficile colitis in children (pilot studies): 10¹⁰ CFU in skim milk or 1.2 × 10⁹ CFU in lyophilized powder daily.
• Functional gastrointestinal disorders in children: Six billion CFU per capsule (6 × 10⁹ CFU), with proven symptom reduction in children.

7. Safety Considerations and Known Interactions

7.1 General Safety Profile

L. rhamnosus is generally well tolerated in healthy people; adverse events are usually mild gastrointestinal symptoms such as bloating and flatulence. Serious invasive infections are very rare and occur predominantly in severely immunocompromised or device-bearing patients.

Based on data from eight of the included RCTs in the 2015 AAD meta-analysis, LGG was well tolerated and adverse events were comparable between treatment and control groups.

The use of LGG in a wide variety of clinical trials without serious adverse events has confirmed its safety in general populations.

7.2 Risk of Bacteremia and Serious Infection

Rare but clinically significant adverse events have been documented in vulnerable populations. A review of probiotic safety concluded that adverse effects of probiotics were correlated with: (i) impaired intestinal barrier function, (ii) immune-compromised state, and (iii) presence of a central venous catheter.

Cases specifically reported for LGG show that these risk factors may play a role; for instance, a number of infants treated with LGG for short gut syndrome associated with intestinal friability appeared to manifest sepsis with LGG-like bacteria, and an ulcerative colitis patient was diagnosed with LGG bacteremia.

A case of empyema in a cardiothoracic transplant recipient with a medical history of HIV infection who was receiving a probiotic containing LGG has been described, and there is at least one reported case of sepsis by L. rhamnosus in a female aortic heart valve recipient, most likely caused by bacterial translocation through a weakened intestinal barrier.

A case report has described a 56-year-old multi-traumatised but immunocompetent woman who was given L. rhamnosus GG as a probiotic and later developed a bloodstream infection with L. rhamnosus GG.

In years 2019, 2020, and 2021, a total of 17, 15, and 16 cases of lactobacilli infection (including endocarditis, bacteremia, and other infections) were reported, and these annual numbers are higher than those observed previously. Lacticaseibacillus rhamnosus — comprising 13 cases, including strain GG (ATCC 53103) — was the most frequently implicated species.

These bacteria cause rare infections mostly in diabetic and immunocompromised subjects in the presence of risk factors such as prosthetic heart valves and dental procedures or caries.

7.3 Epidemiological Safety Data

Despite a markedly increased consumption of Lactobacillus GG in Finland — from 1 liter per person per year to 6 liters per person per year over the study period — there was no change in the prevalence of L. bacteremia. A similar 6-year examination in Sweden, during which there was increasing use of three commercial probiotic Lactobacillus strains, likewise showed no change in the rate of lactobacillemia, and no case of Lactobacillus isolated from the blood stream was identified as being related to the probiotic strains.

In an epidemiological study of Lactobacillus bacteremia in Finland, researchers did not find any correlation between the increased probiotic use of L. rhamnosus GG (ATCC 53103) and the incidence of Lactobacillus bacteremia during 1990–2000.

7.4 High-Risk Populations and Regulatory Cautions

The FDA has identified immunosuppression, structural heart disease, inpatient status, pregnancy, and potential for translocation of probiotics across the bowel wall as factors that may place individuals at higher risk for adverse events in probiotic clinical trials.

Mostly deemed as low-virulence or concomitant, Lactobacillus spp. might be an opportunistic pathogen in immunocompromised and transplant patients and might be related to increased mortality.

Although probiotics are generally considered safe, their safety in immunocompromised patients is uncertain; until more research is available to confirm their safety, caution is warranted when using them in this population.

Harm-reporting in published RCTs assessing probiotics, prebiotics, and synbiotics has been characterized as often lacking or inadequate; it cannot be broadly concluded that these interventions are safe without reporting safety data.

7.5 Antibiotic Sensitivity

Evidence on LGG survival under amoxicillin/clavulanate therapy in children is clinically relevant: LGG's sensitivity to penicillin might make this probiotic ineffective when co-administered with amoxicillin/clavulanate. This sensitivity is a practical consideration when LGG is used concurrently with certain antibiotic classes for AAD prevention.

7.6 Common Mild Adverse Events

Common adverse events reported in trials include transient bloating, gas, and mild abdominal discomfort in approximately 1%–10% of subjects. Rare events include allergic reactions (less than 0.1%) and probiotic-associated bacteremia or endocarditis in case reports from high-risk patients.

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