Safety Profile
Known Safety Concerns
- Bacteremia reported in rare cases in immunocompromised patients
- NOT recommended in critical illness or severe immunosuppression
- Quality varies -- many products do not deliver stated CFU at expiry
- LGG and other strains have different evidence bases -- strain specification matters
Contraindications
- Bacteremia reported in rare cases in immunocompromised patients
- NOT recommended in critical illness or severe immunosuppression
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Lactobacillus rhamnosus GG (LGG) is one of the most extensively studied probiotic strains, with the strongest evidence base for prevention and treatment of antibiotic-associated diarrhea in children and adults. Generally very safe. Same immunocompromised patient warnings apply. LGG specifically has been found in rare case reports to cause bacteremia in immunocompromised and critically ill patients.
Biological and Chemical Classification
- Scientific Name
- Lacticaseibacillus rhamnosus (formerly Lactobacillus rhamnosus)
Mechanism of Action
Information not yet available for this ingredient profile.
Clinical Evidence of Effectiveness
Information not yet available for this ingredient profile.
Pharmacokinetics
Information not yet available for this ingredient profile.
Recommended Dosage
Information not yet available for this ingredient profile.
SETI — Scientific Evidence Transparency Index
Executive Summary — Ingredient Assessment
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or RCT)
- Main clinical benefit observed: Botanical
- Evidence consistency: High consistency across studies (100%)
- Bacteremia reported in rare cases in immunocompromised patients
- NOT recommended in critical illness or severe immunosuppression
- Quality varies -- many products do not deliver stated CFU at expiry
- LGG and other strains have different evidence bases -- strain specification matters
The available scientific evidence for Lactobacillus Rhamnosus indicates notable safety signals that warrant caution. Use should be considered carefully and monitored, particularly in sensitive populations or alongside other medications.
Total SETI Score
High risk| Evidence quality | 10/40 |
| Evidence consistency | 20/20 |
| Safety signals | 0/20 |
| Study recency | 10/10 |
| Evidence transparency | 10/10 |
Evidence Summary
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or systematic review)
- 0 studies identified benefits or no safety concern (GREEN)
- 10 studies reported limited or advisory safety evidence (YELLOW)
Evidence Policy
Only peer-reviewed scientific literature indexed in PubMed or comparable databases is included in this evaluation. Commercial websites, blogs, and marketing materials are excluded. All references include direct traceable links to source documents.
Last updated: 24 მარ 2026, 09:12
Evidence Distribution
-
Observational / other LOW evidence YELLOWProbiotic Supplementation as an Alternative to Antibiotics in Bovine Sperm Cryopreservation: Effects on Motility, Oxidative Stress and Apoptosis. ↗u00d6mu00fcr AD et al.. Probiotic Supplementation as an Alternative to Antibiotics in Bovine Sperm Cryopreservation: Effects on Motility, Oxidative Stress and Apoptosis.. Reprod Domest Anim. 2026. PMID:41853987.PMID 41853987 ↗Journal Reprod Domest AnimYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41853987/
-
Observational / other LOW evidence YELLOWA bile acid-GPBAR1 network supports anti-inflammatory and anti-fibrotic benefits of probiotics in colitis. ↗Biagioli M et al.. A bile acid-GPBAR1 network supports anti-inflammatory and anti-fibrotic benefits of probiotics in colitis.. Gut Microbes. 2026. PMID:41851067.PMID 41851067 ↗Journal Gut MicrobesYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41851067/
-
Observational / other LOW evidence YELLOWProbiotic Lactobacillus rhamnosus mitigates PBC-like features in Mcpip1-deficient mice via modulation of gut-liver crosstalk. ↗Trzos K et al.. Probiotic Lactobacillus rhamnosus mitigates PBC-like features in Mcpip1-deficient mice via modulation of gut-liver crosstalk.. Biochim Biophys Acta Mol Basis Dis. 2026. PMID:41846103.PMID 41846103 ↗Journal Biochim Biophys Acta Mol Basis DisYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41846103/
-
Observational / other LOW evidence YELLOWThe Combination of Lactobacillus reuteri RC-14(u00ae) and Lactobacillus rhamnosus GR-1(u00ae) Induces Anxiolytic-like and Antidepressant-like Effects via Estrogenic Receptors in Ovariectomized Rats. ↗Rosas-Su00e1nchez GU et al.. The Combination of Lactobacillus reuteri RC-14(u00ae) and Lactobacillus rhamnosus GR-1(u00ae) Induces Anxiolytic-like and Antidepressant-like Effects via Estrogenic Receptors in Ovariectomized Rats.. Nutrients. 2026. PMID:41829884.PMID 41829884 ↗Journal NutrientsYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41829884/
-
Observational / other LOW evidence YELLOWInfluence of Singular First Foods on the Infant Gut Microbiome: A Randomized Controlled Trial. ↗Ferro LE et al.. Influence of Singular First Foods on the Infant Gut Microbiome: A Randomized Controlled Trial.. J Nutr. 2026. PMID:41825736.PMID 41825736 ↗Journal J NutrYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41825736/
-
Observational / other LOW evidence YELLOWEfficacy of a probiotic-prebiotic mix on chronic constipation symptoms in the elderly: results of a pilot study. ↗Montarsolo P et al.. Efficacy of a probiotic-prebiotic mix on chronic constipation symptoms in the elderly: results of a pilot study.. Minerva Gastroenterol (Torino). 2026. PMID:41823986.PMID 41823986 ↗Journal Minerva Gastroenterol (Torino)Year 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41823986/
-
Observational / other LOW evidence YELLOWStructure-activity relationship of Laminaria japonica polysaccharide in promoting acetic acid synthesis by Lactobacillus rhamnosus GG. ↗Wu J et al.. Structure-activity relationship of Laminaria japonica polysaccharide in promoting acetic acid synthesis by Lactobacillus rhamnosus GG.. Food Res Int. 2026. PMID:41819923.PMID 41819923 ↗Journal Food Res IntYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41819923/
-
Observational / other LOW evidence YELLOWLactobacillus rhamnosus confers protection against enteropathogenic bacteria by enhancing mucosal immunity and epithelial barrier function. ↗Gao X et al.. Lactobacillus rhamnosus confers protection against enteropathogenic bacteria by enhancing mucosal immunity and epithelial barrier function.. Front Cell Infect Microbiol. 2026. PMID:41809989.PMID 41809989 ↗Journal Front Cell Infect MicrobiolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41809989/
-
Observational / other LOW evidence YELLOWImpact of continuous probiotic supplementation on intestinal barrier function and hepatic biomarkers in fulminant liver failure models. ↗Wu C et al.. Impact of continuous probiotic supplementation on intestinal barrier function and hepatic biomarkers in fulminant liver failure models.. Front Cell Infect Microbiol. 2026. PMID:41798748.PMID 41798748 ↗Journal Front Cell Infect MicrobiolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41798748/
-
Observational / other LOW evidence YELLOWProbiotic Lactobacillus rhamnosus GKLC1 enhances endurance and metabolism in mice with low exercise capacity. ↗Tsai YS et al.. Probiotic Lactobacillus rhamnosus GKLC1 enhances endurance and metabolism in mice with low exercise capacity.. BMC Res Notes. 2026. PMID:41792776.PMID 41792776 ↗Journal BMC Res NotesYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41792776/
Score Transparency
0 of 10 approved references (score saturates at 10). More peer-reviewed studies = stronger evidence base.
Method: Q = number of approved references ÷ 10 (capped at 1.0)
Limited — mostly case reports or animal studies
Method: L = mean study-level weight across approved references. Level 1 (meta-analysis / systematic review) = 1.0; Level 2 (RCT) = 0.8; Level 3 (cohort/case-control) = 0.6; Level 4 (case report) = 0.4; Level 5 (animal / in-vitro) = 0.2.
Mixed or neutral — roughly equal benefit and risk signals
Method: D = (sum of risk-scored references − sum of benefit-scored references) ÷ total evidence score, then scaled from [−1, 1] to [0, 1]. 0.0 = pure benefit; 0.5 = neutral; 1.0 = pure risk.
One or more monitoring-level safety signals active
Method: S = 0.5 (neutral baseline) + sum of active signal severity deltas ÷ 10. Severity deltas: Critical = +2.0, High = +1.5, Moderate = +1.0, Low = +0.5. Capped at 1.0.
Final GIRI Score for Lactobacillus Rhamnosus. Risk level thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
Full methodology & data sources
The GIRI Score is computed entirely from structured data — no editorial scoring or subjective weighting is applied at any step.
- References: Only approved references are counted. Each reference is assigned an evidence level (L1–L5) and a direction (risk / neutral / benefit) by the reference manager or AI classifier.
- Safety Signals: Sourced from regulatory agencies (FDA, EMA, Health Canada, TGA, and others) and pharmacovigilance databases. Only active signals count toward the score.
- Formula version: GIRI Score v3.7.0 — Q × L × D × S × 10.
- Limitations: The score reflects published evidence and recorded signals as of the last update date. It is not a clinical risk assessment and should not replace advice from a qualified healthcare professional.
Risk Level Classification
Based on available regulatory signals and scientific evidence, this ingredient presents a low safety concern under normal conditions of use.
0–3.0
3.0–5.5
5.5–7.5
7.5–10
The score pin shows exactly where this ingredient falls on the fixed risk scale.
What drove the Low classification for Lactobacillus Rhamnosus
A score of 2.0 places this ingredient in the Low band. Thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
0 approved references.
Limited — mostly case reports or animal studies (Level 4–5).
Neutral or mixed — benefit and risk signals roughly balanced.
No active signals — S component is at neutral baseline (0.5), contributing no extra risk weight.
No major regulatory restrictions or advisories recorded across monitored jurisdictions (FDA, EMA, Health Canada, TGA, and others).
How are the Low / Moderate / High / Critical thresholds defined?
The four risk levels are fixed score bands. A score is assigned to exactly one level based on where it falls:
| Level | Score | Meaning |
|---|---|---|
| LOW | 0.0 – 2.9 | Sparse or predominantly beneficial evidence. No active safety alerts. |
| MODERATE | 3.0 – 5.4 | Mixed signals — some risk alongside benefit. Caution at high doses or in sensitive groups. |
| HIGH | 5.5 – 7.4 | Multiple studies or regulatory alerts documenting adverse effects. Professional oversight recommended. |
| CRITICAL | 7.5 – 10 | Regulatory restrictions in one or more major jurisdictions. Serious documented harm. Avoid without specialist supervision. |
Thresholds are fixed constants (GIRI_Score_Utils::LEVEL_THRESHOLDS). They do not change per ingredient and are never subject to editorial adjustment.