At Creative Biolabs, we are a leading Contract Research Organization (CRO) dedicated to providing comprehensive and reliable probiotic toxicology assessment services in various animal models. Our state-of-the-art facilities, experienced scientific team, and adherence to Good Laboratory Practice standards ensure the highest quality data for your probiotic product development, regulatory submissions, and safety evaluations. Request a quote
Overview
The increasing consumption of probiotic-containing products necessitates rigorous safety evaluations. While generally recognized as safe (GRAS), certain probiotics, especially novel strains or those intended for specific populations, may pose potential risks. Our toxicology assessment services are designed to identify and characterize any adverse effects, ensuring the safety and efficacy of your probiotic formulations before they reach the market. We offer a full spectrum of studies, from acute to chronic toxicity, tailored to meet your specific research and regulatory requirements.
Detailed Service Contents
Evaluation of adverse effects following a single or short-term oral administration of the probiotic.
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OECD 420, 423, 425.
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Observation period of up to 14 days.
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Endpoints: Mortality, clinical signs, body weight, food/water consumption, gross pathology.
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Long-term daily oral administration for 6-12 months.
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Evaluates long-term effects and potential for cumulative toxicity.
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Endpoints: Comprehensive assessment similar to sub-chronic studies, with extended observation.
Assessment of the probiotic's potential to induce genetic damage (mutations, chromosomal aberrations).
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Bacterial Reverse Mutation Test (Ames Test, OECD 471): To detect gene mutations.
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In Vitro Mammalian Chromosomal Aberration Test (OECD 473): To detect structural and numerical chromosomal aberrations.
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In Vivo Mammalian Erythrocyte Micronucleus Test (OECD 474): To detect chromosomal damage or spindle dysfunction.
(28-day, 90-day)
Assessment of repeated dose toxicity over an extended period to identify target organs and dose-response relationships.
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OECD 407, 408.
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Repeated daily oral administration for 28 days (sub-acute) or 90 days (sub-chronic).
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Endpoints: Clinical signs, body weight, food/water consumption, ophthalmology, hematology, clinical biochemistry, urinalysis, gross pathology, organ weights, histopathology of target organs.
Investigating the probiotic's potential to modulate or suppress the immune system.
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Splenocyte proliferation assays.
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Cytokine profiling.
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Flow cytometry for immune cell populations.
Assessing effects on fertility, embryonic development, and offspring health.
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Developmental toxicity studies (e.g., OECD 414).
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Reproduction toxicity studies (e.g., OECD 416).
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Behavioral observations, functional observational battery (FOB), and neuropathology.
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Evaluates potential adverse effects on the nervous system.
While probiotics are typically non-systemic, we can assess their persistence, colonization, and metabolic activity within the gastrointestinal tract and potential translocation.
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Our Streamlined Work Process
Our streamlined work process ensures efficiency, transparency, and high-quality results.
Sample Information
To ensure accurate and effective study execution, please provide the following information regarding your probiotic sample:
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Items
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Details
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Samples
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We conduct toxicology assessments for a wide range of probiotic products, including:
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Live Bacterial Strains (e.g., Lactobacillus, Bifidobacterium, Saccharomyces)
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Multi-Strain Probiotic Formulations
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Probiotic-Containing Foods (yogurts, fermented milk, cereals, snacks)
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Probiotic Dietary Supplements (capsules, powders, gummies)
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Probiotic-Based Biotherapeutics
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Postbiotics and Paraprobiotics (non-viable microbial cells or their components)
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Genetically Modified Probiotics
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Probiotic Strain(s)
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Full scientific name (genus, species, strain designation).
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Source and isolation history.
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Genetic characterization (if available).
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Product Form
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Lyophilized powder, liquid suspension, encapsulated, etc.
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Viable Cell Count
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CFU/g or CFU/mL at the time of shipment and expected stability.
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Purity & Contamination
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Certificate of Analysis (CoA) confirming purity and absence of contaminants (e.g., pathogens, heavy metals, mycotoxins).
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Storage & Shipping
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Clear instructions for storage and shipping conditions to maintain product integrity.
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Safety Data Sheet (SDS)
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If available, to ensure safe handling.
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Batch Number & Manufacturing Date.
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Any prior toxicity data or relevant research.
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Delivery Standards
Comprehensive Reports: Detailed final reports including all raw data, statistical analysis, histopathology images, and expert interpretation.
Turnaround Time
Turnaround times vary significantly depending on the complexity, duration, and type of study.
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Acute Oral Toxicity: Typically 4-6 weeks from study initiation to final report.
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Sub-acute (28-day) Oral Toxicity: Approximately 10-12 weeks.
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Sub-chronic (90-day) Oral Toxicity: Approximately 16-20 weeks.
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Genotoxicity Studies: 6-10 weeks per assay.
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Chronic Toxicity / Reproductive Studies: Timelines will be discussed during the consultation phase due to their extended duration.
Note: These are estimates. Specific timelines will be provided in your customized study proposal.
Advantages of Partnering with Creative Biolabs
Experienced Scientific Team
Toxicologists, veterinarians, pathologists, and microbiologists with extensive expertise in probiotic research.
Customized Study Design
Tailored protocols to meet your unique product and regulatory needs.
Comprehensive Endpoints
Broad range of analyses for in-depth safety characterization.
State-of-the-Art Equipment
Advanced analytical platforms for accurate and reliable results.
Ethical Animal Care
Commitment to animal welfare and adherence to the highest ethical standards.
Dedicated Project Management
A single point of contact to ensure seamless communication and project progression.
Cost-Effective Solutions
High-quality research at competitive prices.
Applications
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Novel Probiotic Strain Development: Safety evaluation of new bacterial or yeast strains.
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Functional Foods & Beverages: Assessing the safety of probiotic-fortified products.
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Dietary Supplements: Ensuring the safety of probiotic supplements.
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Pharmaceutical Probiotics: Pre-clinical safety data for drug development.
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Veterinary Probiotics: Safety assessment for animal health products.
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Regulatory Submissions: Providing critical safety data for GRAS notifications, novel food applications, and other regulatory approvals.
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Product Repositioning/Reformulation: Re-evaluating safety for changes in formulation or intended use.
Necessity of Probiotic Toxicology Assessment
While probiotics are generally considered safe, the necessity of a thorough toxicology assessment arises from several factors:
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Regulatory Requirements: Most regulatory bodies worldwide require robust safety data for novel food ingredients, dietary supplements, and pharmaceutical products containing probiotics.
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Strain-Specific Effects: Safety is often strain-specific. A probiotic strain deemed safe in one context may not be safe in another, or a novel strain may have unforeseen effects.
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Dose-Dependent Effects: Even beneficial substances can exhibit adverse effects at high doses.
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Vulnerable Populations: Probiotics intended for infants, immunocompromised individuals, or those with underlying health conditions require extra scrutiny.
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Contamination Risks: Manufacturing processes can introduce contaminants that require assessment.
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Consumer Safety & Trust: Demonstrating comprehensive safety builds consumer confidence and protects your brand reputation.
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Intellectual Property & Market Advantage: Robust safety data can differentiate your product and support patent applications.
Contact us today for a confidential consultation and a customized study proposal. Let Creative Biolabs be your trusted partner in probiotic toxicology assessment. Our experts are here to guide you through every step.
FAQs
What animal models do you typically use for probiotic toxicology?
We primarily use rodents (rats and mice) due to their well-established use in toxicology, genetic homogeneity, and cost-effectiveness. Other models, like rabbits or mini-pigs, may be used for specific studies or regulatory requirements.
How do you ensure the viability of probiotics during the study?
We implement strict protocols for probiotic handling, storage, and administration, including regular viable cell count verification of the test substance throughout the study to ensure animals receive the intended dose.
What is the minimum amount of probiotic sample required?
The required amount depends on the study type, duration, and dose levels. We will provide a precise estimate during the study design phase. It's crucial to provide enough material to cover the entire study duration, including any stability testing.
