Safety Profile
Known Safety Concerns
- Theoretical bacteremia risk in severely immunocompromised patients
- Limited oral bioavailability for vaginal applications
Contraindications
- Theoretical bacteremia risk in severely immunocompromised patients
- Limited oral bioavailability for vaginal applications
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Lactobacillus crispatus is the dominant Lactobacillus species in a healthy vaginal microbiome. Used for bacterial vaginosis prevention and vaginal health. Generally considered safe. Theoretical bacteremia risk in severely immunocompromised individuals.
Biological and Chemical Classification
- Scientific Name
- Lactobacillus crispatus
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: Probiotic
- Evidence consistency: High consistency across studies (100%)
- Theoretical bacteremia risk in severely immunocompromised patients
- Limited oral bioavailability for vaginal applications
The available scientific evidence for Lactobacillus crispatus 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: 25 მარ 2026, 22:33
Evidence Distribution
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Observational / other LOW evidence YELLOWLactobacillus combination alleviates dextran sulfate sodium-induced colitis in Wuzhishan minipigs. ↗Wang X et al.. Lactobacillus combination alleviates dextran sulfate sodium-induced colitis in Wuzhishan minipigs.. Food Funct. 2026. PMID:41860415.PMID 41860415 ↗Journal Food FunctYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41860415/
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Observational / other LOW evidence YELLOWVIBRANT: A phase 1 randomized trial of multi-strain vaginal L. crispatus live biotherapeutic products in people with bacterial vaginosis. ↗Potloane D et al.. VIBRANT: A phase 1 randomized trial of multi-strain vaginal L. crispatus live biotherapeutic products in people with bacterial vaginosis.. Cell Host Microbe. 2026. PMID:41856107.PMID 41856107 ↗Journal Cell Host MicrobeYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41856107/
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Observational / other LOW evidence YELLOWPreventive effects of synbiotic supplementation against Salmonella Enteritidis infection in broiler chickens. ↗Babot JD et al.. Preventive effects of synbiotic supplementation against Salmonella Enteritidis infection in broiler chickens.. Can J Microbiol. 2026. PMID:41855562.PMID 41855562 ↗Journal Can J MicrobiolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41855562/
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Observational / other LOW evidence YELLOWIntegrating microbiome insights into cervical cancer. ↗Bautista J et al.. Integrating microbiome insights into cervical cancer.. Front Med (Lausanne). 2026. PMID:41846893.PMID 41846893 ↗Journal Front Med (Lausanne)Year 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41846893/
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Observational / other LOW evidence YELLOWMachine learning-based prediction of BV-relevant probiotic functional potential in vaginal-derived Lactobacillus crispatus strains. ↗Quan K et al.. Machine learning-based prediction of BV-relevant probiotic functional potential in vaginal-derived Lactobacillus crispatus strains.. BMC Microbiol. 2026. PMID:41845201.PMID 41845201 ↗Journal BMC MicrobiolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41845201/
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Observational / other LOW evidence YELLOWA microbiota-host axis mediates prostaglandin sensitivity: Lactobacillus crispatus as a biomarker and regulator of human labor induction. ↗Wang Z et al.. A microbiota-host axis mediates prostaglandin sensitivity: Lactobacillus crispatus as a biomarker and regulator of human labor induction.. NPJ Biofilms Microbiomes. 2026. PMID:41839898.PMID 41839898 ↗Journal NPJ Biofilms MicrobiomesYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41839898/
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Observational / other LOW evidence YELLOWMechanisms and Therapeutic Implications of Microbiome-Mediated Immune Dysregulation in Recurrent Pregnancy Loss and Implantation Failure. ↗Bahia W et al.. Mechanisms and Therapeutic Implications of Microbiome-Mediated Immune Dysregulation in Recurrent Pregnancy Loss and Implantation Failure.. Am J Reprod Immunol. 2026. PMID:41830530.PMID 41830530 ↗Journal Am J Reprod ImmunolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41830530/
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Observational / other LOW evidence YELLOWEffects of dietary Chinese yam- Rehmannia glutinosa 'medicine pair' on growth performance, body size trait, slaughtering performance, antioxidant capacity, and cecum microbiota… ↗Zhang J et al.. Effects of dietary Chinese yam- Rehmannia glutinosa 'medicine pair' on growth performance, body size trait, slaughtering performance, antioxidant capacity, and cecum microbiota of broilers.. Front Nutr. 2026. PMID:41821862.PMID 41821862 ↗Journal Front NutrYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41821862/
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Observational / other LOW evidence YELLOWVaginal-Derived Potential Probiotics and Their Postbiotics Alleviate Aerobic Vaginitis via Suppressing TLR4/MyD88/NF-u03baB Signalling Pathway and Potentially Enhancing Vaginal Barrier. ↗Tian M et al.. Vaginal-Derived Potential Probiotics and Their Postbiotics Alleviate Aerobic Vaginitis via Suppressing TLR4/MyD88/NF-u03baB Signalling Pathway and Potentially Enhancing Vaginal Barrier.. Microb Biotechnol. 2026. PMID:41807990.PMID 41807990 ↗Journal Microb BiotechnolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41807990/
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Observational / other LOW evidence YELLOWIntegrated cross-sectional study and functional validation indicate the association of lactobacillus crispatus-derived D-lactic acid with cervical gene expression and precancerous cervical lesions. ↗Dai W et al.. Integrated cross-sectional study and functional validation indicate the association of lactobacillus crispatus-derived D-lactic acid with cervical gene expression and precancerous cervical lesions.. J Transl Med. 2026. PMID:41803943.PMID 41803943 ↗Journal J Transl MedYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41803943/
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 crispatus. 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 crispatus
A score of 1.5 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.